Trial Outcomes & Findings for Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection (NCT NCT04481633)
NCT ID: NCT04481633
Last Updated: 2026-08-10
Results Overview
Number of patients with positive anti-COVID19 serology depending on whether or not they were taking Hydroxy-Chloroquine
COMPLETED
NA
547 participants
12 months post inclusion
2026-08-10
Participant Flow
Participant milestones
| Measure |
HCQ+IS+ Group
Patients treated with Hydroxychloroquine and Immunosuppressants with SLE/GS or other connective tissue disease
|
HCQ+IS- Group
Patients treated with Hydroxychloroquine and without immunosuppressants with SLE/GS or other connective tissue disease diagnosed
|
HCQ-IS+ Group
Patients not treated with Hydroxychloroquine and Immunosuppressants with a diagnosis of SLE/GS or other connective tissue disease
|
HCQ-IS- Group
Patients not treated with Hydroxychloroquine and without immunosuppressants with viral Hepatitis C cured for more than 12 months or primary biliary cholangitis (PBC)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
112
|
121
|
115
|
199
|
|
Overall Study
COMPLETED
|
50
|
54
|
54
|
112
|
|
Overall Study
NOT COMPLETED
|
62
|
67
|
61
|
87
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HCQ+IS+ Group
n=112 Participants
Patients treated with Hydroxychloroquine and Immunosuppressants with SLE/GS or other connective tissue disease
|
HCQ+IS- Group
n=121 Participants
Patients treated with Hydroxychloroquine and without immunosuppressants with SLE/GS or other connective tissue disease diagnosed
|
HCQ-IS+ Group
n=115 Participants
Patients not treated with Hydroxychloroquine and Immunosuppressants with a diagnosis of SLE/GS or other connective tissue disease
|
HCQ-IS- Group
n=199 Participants
Patients not treated with Hydroxychloroquine and without immunosuppressants with viral Hepatitis C cured for more than 12 months or primary biliary cholangitis (PBC)
|
Total
n=547 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.50 Years
STANDARD_DEVIATION 13.23 • n=112 Participants
|
45.73 Years
STANDARD_DEVIATION 13.60 • n=121 Participants
|
55.52 Years
STANDARD_DEVIATION 30.47 • n=115 Participants
|
61.47 Years
STANDARD_DEVIATION 12.14 • n=199 Participants
|
53.95 Years
STANDARD_DEVIATION 19.17 • n=547 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=112 Participants
|
107 Participants
n=121 Participants
|
90 Participants
n=115 Participants
|
117 Participants
n=199 Participants
|
418 Participants
n=547 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=112 Participants
|
14 Participants
n=121 Participants
|
25 Participants
n=115 Participants
|
82 Participants
n=199 Participants
|
129 Participants
n=547 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Polymedicated patient
|
72 Participants
n=112 Participants
|
49 Participants
n=121 Participants
|
60 Participants
n=115 Participants
|
71 Participants
n=199 Participants
|
252 Participants
n=547 Participants
|
PRIMARY outcome
Timeframe: 12 months post inclusionNumber of patients with positive anti-COVID19 serology depending on whether or not they were taking Hydroxy-Chloroquine
Outcome measures
| Measure |
HCQ+IS+ Group
n=112 Participants
Patients treated with Hydroxychloroquine and Immunosuppressants with SLE/GS or other connective tissue disease
|
HCQ+IS- Group
n=121 Participants
Patients treated with Hydroxychloroquine and without immunosuppressants with SLE/GS or other connective tissue disease diagnosed
|
HCQ-IS+ Group
n=115 Participants
Patients not treated with Hydroxychloroquine and Immunosuppressants with a diagnosis of SLE/GS or other connective tissue disease
|
HCQ-IS- Group
n=199 Participants
Patients not treated with Hydroxychloroquine and without immunosuppressants with viral Hepatitis C cured for more than 12 months or primary biliary cholangitis (PBC)
|
|---|---|---|---|---|
|
Number of Participants With Positive Anti-SARS-CoV-2 Serology
|
31 Participants
|
30 Participants
|
12 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: From inclusion until the end of the study (at M12)Percentage of patients who experienced symptomatic or severe (hospitalization) COVID-19 infection, as determined by the self-administered questionnaire and medical consultation. Each subject will complete a self-administered questionnaire at the enrollment visit, describing the main symptoms of COVID-19 infection by answering "yes" or "no" to the various items. The physician will then conduct a medical assessment of the symptoms and their severity.
Outcome measures
| Measure |
HCQ+IS+ Group
n=112 Participants
Patients treated with Hydroxychloroquine and Immunosuppressants with SLE/GS or other connective tissue disease
|
HCQ+IS- Group
n=121 Participants
Patients treated with Hydroxychloroquine and without immunosuppressants with SLE/GS or other connective tissue disease diagnosed
|
HCQ-IS+ Group
n=115 Participants
Patients not treated with Hydroxychloroquine and Immunosuppressants with a diagnosis of SLE/GS or other connective tissue disease
|
HCQ-IS- Group
n=199 Participants
Patients not treated with Hydroxychloroquine and without immunosuppressants with viral Hepatitis C cured for more than 12 months or primary biliary cholangitis (PBC)
|
|---|---|---|---|---|
|
Number of Patients Who Experienced Symptomatic or Severe (Hospitalization) COVID-19 Infection
|
23 Participants
|
17 Participants
|
7 Participants
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post inclusionPopulation: The discrepancy between the number of participants analyzed in this OM and the overall number reported in the Participants Flow section is due to missing data; some patients did not have these data available.
Percentage of patients with anti-COVID19 serology indicating effective vaccine protection. Vaccine protection efficacy is measured by the presence of a post-vaccination antibody titer greater than 140 BAU/mL.
Outcome measures
| Measure |
HCQ+IS+ Group
n=64 Participants
Patients treated with Hydroxychloroquine and Immunosuppressants with SLE/GS or other connective tissue disease
|
HCQ+IS- Group
n=72 Participants
Patients treated with Hydroxychloroquine and without immunosuppressants with SLE/GS or other connective tissue disease diagnosed
|
HCQ-IS+ Group
n=74 Participants
Patients not treated with Hydroxychloroquine and Immunosuppressants with a diagnosis of SLE/GS or other connective tissue disease
|
HCQ-IS- Group
n=139 Participants
Patients not treated with Hydroxychloroquine and without immunosuppressants with viral Hepatitis C cured for more than 12 months or primary biliary cholangitis (PBC)
|
|---|---|---|---|---|
|
Number of Patients With Anti-COVID19 Serology Indicating Effective Vaccine Protection
|
48 Participants
|
65 Participants
|
65 Participants
|
119 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post iclusionPopulation: The discrepancy between the number of participants analyzed in this OM and the overall number reported in the Participants Flow section is due to missing data; some patients did not have these data available.
Rate of patient with elevated post-vaccination antibody titers according to treatment type and group
Outcome measures
| Measure |
HCQ+IS+ Group
n=61 Participants
Patients treated with Hydroxychloroquine and Immunosuppressants with SLE/GS or other connective tissue disease
|
HCQ+IS- Group
n=71 Participants
Patients treated with Hydroxychloroquine and without immunosuppressants with SLE/GS or other connective tissue disease diagnosed
|
HCQ-IS+ Group
n=72 Participants
Patients not treated with Hydroxychloroquine and Immunosuppressants with a diagnosis of SLE/GS or other connective tissue disease
|
HCQ-IS- Group
n=138 Participants
Patients not treated with Hydroxychloroquine and without immunosuppressants with viral Hepatitis C cured for more than 12 months or primary biliary cholangitis (PBC)
|
|---|---|---|---|---|
|
Number of Participants With Elevated Post-vaccination Antibody Titer
|
22 Participants
|
36 Participants
|
25 Participants
|
41 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post inclusionNumber of patients who accepted the anti-COVID-19 vaccination, which allows us to obtain the acceptance rate of the Covid-19 vaccination according to the 4 groups studied in the protocol
Outcome measures
| Measure |
HCQ+IS+ Group
n=112 Participants
Patients treated with Hydroxychloroquine and Immunosuppressants with SLE/GS or other connective tissue disease
|
HCQ+IS- Group
n=121 Participants
Patients treated with Hydroxychloroquine and without immunosuppressants with SLE/GS or other connective tissue disease diagnosed
|
HCQ-IS+ Group
n=115 Participants
Patients not treated with Hydroxychloroquine and Immunosuppressants with a diagnosis of SLE/GS or other connective tissue disease
|
HCQ-IS- Group
n=199 Participants
Patients not treated with Hydroxychloroquine and without immunosuppressants with viral Hepatitis C cured for more than 12 months or primary biliary cholangitis (PBC)
|
|---|---|---|---|---|
|
Number of Patients Who Accepted the Anti-COVID-19 Vaccination
|
76 Participants
|
83 Participants
|
86 Participants
|
148 Participants
|
Adverse Events
HCQ+IS+ Group
HCQ+IS- Group
HCQ-IS+ Group
HCQ-IS- Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Pr Laurent ALRIC
Service de Médecine Interne-Immunologie clinique Pole Digestif Hôpital de Rangueil, CHU Toulouse
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place