101-PGC-005 for the Treatment of COVID-19
NCT05656521 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2023-05-30
Summary
This is a prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety, and tolerability of 101-PGC-005 ('005) when used alongside standard of care (SOC) for the treatment of hospitalized patients with coronavirus disease (COVID-19).
Conditions
Interventions
- DRUG
-
101-PGC-005
'005 is a targeted prodrug of dexamethasone that binds to activated macrophages.
- DRUG
-
Dexamethasone is a glucocorticoid commonly prescribed to treat inflammation.
Sponsors & Collaborators
-
101 Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-31
- Primary Completion
- 2023-04-21
- Completion
- 2023-06-30
Countries
- India
Study Locations
More Related Trials
-
Study on the Safety and Efficacy of Meplazumab for Injection Patients COVID-19
NCT05679492 ·Status: WITHDRAWN ·Phase: PHASE3
-
To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19
NCT05813587 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial Evaluate the Immunogenicity and Safety of Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell)
NCT05616754 ·Status: UNKNOWN ·Phase: PHASE3
-
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
NCT04966871 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis
NCT00696969 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers
NCT05911828 ·Status: RECRUITING ·Phase: PHASE1
-
Study to Assess the Effect of Meplazumab on COVID-19
NCT04586153 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis
NCT05593666 ·Status: COMPLETED ·Phase: PHASE2
-
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria
NCT07235020 ·Status: COMPLETED ·Phase: PHASE2
-
Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...
NCT03952650 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa
NCT01067443 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine
NCT05409261 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis
NCT00508963 ·Status: NO_LONGER_AVAILABLE
-
21-day Double-blind Trial of Albendazole in Adults With Loa Loa Microfilaremia
NCT06613997 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
DSM265 Prophylaxis of Plasmodium Falciparum Malaria
NCT02562872 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity of Recombinant Pichia Pastoris AMA1-DiCo Candidate Malaria Vaccine With GLA-SE and Alhydrogel ® as Adjuvant in Healthy Malaria Non-Exposed European and Malaria Exposed African Adults
NCT02014727 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
NCT04275245 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of NF135 CPS Immunization
NCT03813108 ·Status: TERMINATED ·Phase: NA
-
The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
NCT02530697 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study
NCT05957978 ·Status: COMPLETED ·Phase: PHASE2
-
Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate
NCT06798402 ·Status: RECRUITING ·Phase: PHASE2
-
Public Health Emergency: SOLIDARITY TRIAL Philippines
NCT05024006 ·Status: COMPLETED ·Phase: NA
-
Phase I Study of Safety and Immunogenicity of AMA1-C1Alhydrogel + CPG 7909 Vaccine for Malaria
NCT00414336 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis
NCT00317980 ·Status: COMPLETED ·Phase: PHASE4
-
Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis
NCT01377974 ·Status: COMPLETED ·Phase: PHASE2