Trial Outcomes & Findings for Clinical Trial Evaluating the Efficacy and Safety of Favipiravir in Moderate to Severe COVID-19 Patients (NCT NCT04529499)
NCT ID: NCT04529499
Last Updated: 2022-03-21
Results Overview
This endpoint will be considered to have been met when the patient has attained a score of 4 or lower on the 10-point ordinal scale of clinical status used by WHO in the SOLIDARITY trial (maintaining a blood oxygen saturation of ≥ 95% at rest on room air at sea level) when evaluated over a period of 24 hours.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
353 participants
Primary outcome timeframe
1-28 days
Results posted on
2022-03-21
Participant Flow
Recruitment Period 22 AUG 2020 to 31 DEC 2020. The study was conducted at three hospitals in Kuwait (\[Jaber Al Ahmad Al Jaber Al Sabah Hospital, Kuwait Mishref Field Hospital \[(both of which are designated COVID-19 centers in Kuwait\]) and Farwaniya Hospital, Kuwait)
Participant milestones
| Measure |
Favipiravir + Supportive Care
Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio
|
Placebo + Supportive Care
Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
178
|
|
Overall Study
Discharged From Hospital Before Day 28
|
136
|
136
|
|
Overall Study
Completed 10-day Treatment Course of IMP
|
150
|
147
|
|
Overall Study
Completed Day 14 Telephonic Visit
|
107
|
102
|
|
Overall Study
Completed Day 21 Telephonic Visit
|
119
|
120
|
|
Overall Study
Completed Day 28 Telephonic Visit
|
134
|
131
|
|
Overall Study
Completed Days 14, 21 and 28 Telephonic Visits in Stage I
|
98
|
94
|
|
Overall Study
Continue to be in Hospital as of Day 28
|
6
|
4
|
|
Overall Study
Completed Day 42 Telephonic Visit
|
136
|
135
|
|
Overall Study
Completed Day 60 Telephonic Visit
|
129
|
132
|
|
Overall Study
Completed Days 42 and 60 Telephonic Visits in Stage II
|
126
|
130
|
|
Overall Study
Continued to be in Hospital When Study Was Terminated
|
11
|
17
|
|
Overall Study
COMPLETED
|
139
|
138
|
|
Overall Study
NOT COMPLETED
|
36
|
40
|
Reasons for withdrawal
| Measure |
Favipiravir + Supportive Care
Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio
|
Placebo + Supportive Care
Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Death
|
14
|
11
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Others
|
7
|
11
|
Baseline Characteristics
Clinical Trial Evaluating the Efficacy and Safety of Favipiravir in Moderate to Severe COVID-19 Patients
Baseline characteristics by cohort
| Measure |
Favipiravir + Supportive Care
n=175 Participants
Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio
|
Placebo + Supportive Care
n=178 Participants
Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 12.5 • n=39 Participants
|
52.1 years
STANDARD_DEVIATION 12.5 • n=41 Participants
|
51.9 years
STANDARD_DEVIATION 12.5 • n=35 Participants
|
|
Age, Customized
< 50 years
|
70 Participants
n=39 Participants
|
74 Participants
n=41 Participants
|
144 Participants
n=35 Participants
|
|
Age, Customized
>/= 50 years
|
105 Participants
n=39 Participants
|
104 Participants
n=41 Participants
|
209 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=39 Participants
|
58 Participants
n=41 Participants
|
115 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=39 Participants
|
120 Participants
n=41 Participants
|
238 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
37 Participants
n=39 Participants
|
37 Participants
n=41 Participants
|
74 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
137 Participants
n=39 Participants
|
140 Participants
n=41 Participants
|
277 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Nationality · Bangladeshi
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Nationality · Egyptian
|
10 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Nationality · Indian
|
15 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Nationality · Iranian
|
2 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Nationality · Kuwaiti
|
116 Participants
n=39 Participants
|
116 Participants
n=41 Participants
|
232 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Nationality · Filipino
|
6 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Nationality · Others
|
21 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Body Mass Index
|
30.499 kg / m^2
STANDARD_DEVIATION 6.351 • n=39 Participants
|
31.042 kg / m^2
STANDARD_DEVIATION 6.488 • n=41 Participants
|
30.773 kg / m^2
STANDARD_DEVIATION 6.416 • n=35 Participants
|
|
RT-PCR outcome at hospital admission
Positive on RT-PCR
|
175 Participants
n=39 Participants
|
176 Participants
n=41 Participants
|
351 Participants
n=35 Participants
|
|
RT-PCR outcome at hospital admission
Data Missing
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Clinical Status Score on WHO 10-point ordinal scale
4 = Hospitalized, no oxygen therapy
|
18 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
Clinical Status Score on WHO 10-point ordinal scale
5= Hospitalized, on oxygen
|
156 Participants
n=39 Participants
|
156 Participants
n=41 Participants
|
312 Participants
n=35 Participants
|
|
Clinical Status Score on WHO 10-point ordinal scale
6 = Hospitalized, Oxygen by NIV or high flow
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Clinical Status Score on WHO 10-point ordinal scale
7= Mechanical Ventilation , p/f > 150 or s/f > 200
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Baseline NEWS-2 score based clinical risk category
Low (NEWS 2 score: 0-4)
|
86 Participants
n=39 Participants
|
96 Participants
n=41 Participants
|
182 Participants
n=35 Participants
|
|
Baseline NEWS-2 score based clinical risk category
Low-Medium (NEWS 2 score of 3 in any individual parameter)
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Baseline NEWS-2 score based clinical risk category
Medium (NEWS-2 Score: 5-6)
|
74 Participants
n=39 Participants
|
69 Participants
n=41 Participants
|
143 Participants
n=35 Participants
|
|
Baseline NEWS-2 score based clinical risk category
High (NEWS-2 score: >/= 7)
|
14 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Baseline NEWS-2 score based clinical risk category
Data missing
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Randomization Strata to which assigned
Moderate
|
127 Participants
n=39 Participants
|
129 Participants
n=41 Participants
|
256 Participants
n=35 Participants
|
|
Randomization Strata to which assigned
Severe
|
48 Participants
n=39 Participants
|
49 Participants
n=41 Participants
|
97 Participants
n=35 Participants
|
|
No. of days since onset of first symptom associated with COVID-19
|
7.0 days
n=39 Participants
|
7.0 days
n=41 Participants
|
7.0 days
n=35 Participants
|
PRIMARY outcome
Timeframe: 1-28 daysPopulation: Analysis population (Intent-to-treat) was all randomized patients who had a clinical status score \>4 on WHO 10-point ordinal scale at baseline
This endpoint will be considered to have been met when the patient has attained a score of 4 or lower on the 10-point ordinal scale of clinical status used by WHO in the SOLIDARITY trial (maintaining a blood oxygen saturation of ≥ 95% at rest on room air at sea level) when evaluated over a period of 24 hours.
Outcome measures
| Measure |
Favipiravir + Supportive Care
n=157 Participants
Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio
|
Placebo + Supportive Care
n=158 Participants
Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio
|
|---|---|---|
|
Primary Efficacy Endpoint: Time to Resolution of Hypoxia (Stage I)
|
7 days
Interval 4.0 to 11.0
|
8 days
Interval 5.0 to 12.0
|
SECONDARY outcome
Timeframe: 1-28 daysPopulation: Intention-to-treat
Percentage of Patients dying from any cause over an assessment period from randomization until Day 28 or discharge from hospital (if discharge happens earlier)
Outcome measures
| Measure |
Favipiravir + Supportive Care
n=175 Participants
Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio
|
Placebo + Supportive Care
n=178 Participants
Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio
|
|---|---|---|
|
Percentage of Patients Dying (All Cause (Stage I)
|
11 Participants
|
7 Participants
|
Adverse Events
Favipiravir + Supportive Care
Serious events: 19 serious events
Other events: 18 other events
Deaths: 14 deaths
Placebo + Supportive Care
Serious events: 14 serious events
Other events: 11 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Favipiravir + Supportive Care
n=168 participants at risk
Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio
|
Placebo + Supportive Care
n=166 participants at risk
Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
4.2%
7/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
3.6%
6/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.2%
7/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
2.4%
4/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Renal and urinary disorders
Renal Impairment
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.00%
0/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Investigations
Hepatic Enzymes Increased
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.00%
0/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
General disorders
Chest Pain
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.00%
0/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Infections and infestations
Septic shock
|
0.00%
0/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Cardiac disorders
Myocardial Infarction
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.00%
0/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
Other adverse events
| Measure |
Favipiravir + Supportive Care
n=168 participants at risk
Frequency: Twice daily (morning and evening) Dosage Form: Tablets. Tablet Strength 200 mg. Dosage: 1,800 mg BID on Day 1 + 800 mg BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
AVIGAN: Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio
|
Placebo + Supportive Care
n=166 participants at risk
Frequency: Twice daily (morning and evening) Dosage Form: Tablets Dosage: 9 tablets for BID on Day 1 + 4 tablets BID for next 9 days (maximum). On Day 1, the second dose will be administered with at least a 4-hour interval from administration of the first dose.
Placebo Comparator: Patients will be randomized to the placebo + supportive care group in a 1:1 ratio
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.00%
0/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Investigations
Blood uric acid increased
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Investigations
Hemoglobin decreased
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.00%
0/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Investigations
Hepatic Enzymes Increased
|
3.0%
5/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
3.0%
5/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Investigations
Lipids abnormal
|
0.00%
0/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Investigations
Liver function test increased
|
0.00%
0/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Metabolism and nutrition disorders
Gout
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.00%
0/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Investigations
Hyperuricemia
|
4.8%
8/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.60%
1/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.60%
1/168 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
0.00%
0/166 • Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier)
The All-Cause Mortality is reported for the population of randomized subjects ( = 'Intent-to-treat' population of the study) - 175 subjects in Favipiravir + supportive care and 178 subjects in placebo groups. Serious Adverse Events and Other (Not Including Serious) Adverse Events are reported for the safety population of the study (= randomized and received at least one dose of the study medication) - 168 subjects in Favipiravir + supportive care and 166 subjects in placebo groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication will be a joint effort between Sponsors and Principal Investigator
- Publication restrictions are in place
Restriction type: OTHER