Adults 21 to 80, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Primary Efficacy Endpoint: Time to Resolution of Hypoxia (Stage I)Primary· 1-28 days
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.
Group
Value
95% CI
Favipiravir + Supportive Care
7
4 – 11
Placebo + Supportive Care
8
5 – 12
Percentage of Patients Dying (All Cause (Stage I)Secondary· 1-28 days
Percentage of Patients dying from any cause over an assessment period from randomization until Day 28 or discharge from hospital (if discharge happens earlier)
Group
Value
95% CI
Favipiravir + Supportive Care
11
Placebo + Supportive Care
7
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline ( Day 1) to Day 28 or discharge or study discontinuation ( whichever was earlier).
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a prospective, interventional, multi-centre, phase III, randomized, double blind, placebo-controlled, parallel design trial to evaluate the efficacy, safety and tolerability of favipiravir as adjunct ('add on') to supportive care, in comparison to placebo with supportive care, in the acute treatment of patients who have tested positive for SARS-CoV-2 and presenting with moderate to severe COVID-19.
This study will be conducted in two parts; Stage I - Main study and Stage II - Extended Follow up.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03305341 — Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix
· EARLY_PHASE1
· active not recruiting
NCT06482138 — Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation
· NA
· recruiting
NCT04924803 — Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs
· NA
· active not recruiting
NCT05013632 — COVID-19 International Drug Pregnancy Registry
· recruiting
NCT04806061 — Urine Alkalinisation in COVID-19
· NA
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dr. Reddy's Laboratories Limited
Last refreshed: 21 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04529499.