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NCT04411433
Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19
Phase 3 trial testing Favipiravir (3200 mg + 1200 mg) in Sars-CoV2 in 1,008 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Ministry of Health, Turkey |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,008 |
| Start date | 8 May 2020 |
| Primary completion | 31 December 2020 |
| Estimated completion | 1 June 2021 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Favipiravir (3200 mg + 1200 mg) — full drug profile →
- Favipiravir (3600 mg + 1600 mg)
- Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine — full drug profile →
- Favipiravir (3200 mg + 1200 mg) combined with Azithromycin — full drug profile →
- Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
- Hydroxychloroquine combined with Azithromycin — full drug profile →
Conditions studied
Sponsor
Ministry of Health, Turkey
Who can join
Adults 18 to 70, any sex, with Sars-CoV2 or COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, multicenter, parallel-group, randomized, phase III trial that evaluates the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of patients with possible or confirmed COVID-19 observed within the last 5 days. 1000 patients will be randomized in 2:1:2:2:2:1 ratio and divided into six groups.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
COVID-19: Characteristics and Therapeutics.
Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206 -
An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794 -
The emergence of COVID-19 as a global pandemic: Understanding the epidemiology, immune response and potential therapeutic targets of SARS-CoV-2.
Muralidar S, Ambi SV, Sekaran S, Krishnan UM. · · 2020 · cited 184× · PMID 32971147 · DOI 10.1016/j.biochi.2020.09.018 -
SARS coronavirus 2: from genome to infectome.
Rastogi M, Pandey N, Shukla A, Singh SK. · · 2020 · cited 69× · PMID 33261606 · DOI 10.1186/s12931-020-01581-z -
COVID-19 update: The race to therapeutic development.
Twomey JD, Luo S, Dean AQ, Bozza WP, et al · · 2020 · cited 50× · PMID 33161277 · DOI 10.1016/j.drup.2020.100733 -
Hydroxychloroquine in COVID-19: Potential Mechanism of Action Against SARS-CoV-2.
Satarker S, Ahuja T, Banerjee M, E VB, et al · · 2020 · cited 50× · PMID 32864299 · DOI 10.1007/s40495-020-00231-8 -
SARS-CoV-2: An Update on Potential Antivirals in Light of SARS-CoV Antiviral Drug Discoveries.
Elshabrawy HA. · · 2020 · cited 28× · PMID 32585913 · DOI 10.3390/vaccines8020335 -
Current status and strategic possibilities on potential use of combinational drug therapy against COVID-19 caused by SARS-CoV-2.
Siddiqui AJ, Jahan S, Ashraf SA, Alreshidi M, et al · · 2021 · cited 25× · PMID 32752944 · DOI 10.1080/07391102.2020.1802345
Verify or expand the search:
- PubMed search for NCT04411433
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sars-CoV2
Currently open trials in the same condition.
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- NCT04433364 — COPE - COVID-19 in Pregnancy and Early Childhood · active not recruiting
- NCT04363853 — Tocilizumab Treatment in Patients With COVID-19 · Phase 2 · active not recruiting
- NCT04424992 — The Natural History of Hospitalized COVID-19 Patients · recruiting
Other Ministry of Health, Turkey trials
Trials by the same sponsor.
- NCT07500584 — The Impact of Psychodrama Intervention on the Empathy, Self-compassion and Psychological Well-Being of University Studen · NA · completed
- NCT07505017 — A Positive Psychodrama Intervention to Improve Psychological Well-Being in University Students · NA · completed
- NCT06519188 — The Effect of Salt Water Nebulization on Cough, Sputum and Quality of Life in Chronic Obstructive Pulmonary Patients · NA · completed
- NCT07492810 — The Effect of Peer Video Modeling and 3D Jaw Video Modeling Training on Oral Health and Toothbrushing Skills in Children · NA · completed
- NCT04474457 — Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04411433 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Ministry of Health, Turkey
- Last refreshed: 1 February 2021
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/NCT04411433.
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