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NCT04376814
Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19
NA trial testing Favipiravir in COVID-19 in 40 participants. Completed in 25 May 2020.
5 April 2020
Quick facts
| Lead sponsor | Baqiyatallah Medical Sciences University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 29 March 2020 |
| Primary completion | 5 April 2020 |
| Estimated completion | 25 May 2020 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- Favipiravir (FAVIPIRAVIR) — full drug profile →
- Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
- Lopinavir / Ritonavir — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
- Favipiravir — all drugs for Favipiravir →
- Kaletra — all drugs for Kaletra →
- Hydroxychloroquine — all drugs for Hydroxychloroquine →
Sponsor
Baqiyatallah Medical Sciences University
Who can join
Adults 16 to 100, any sex, with COVID-19 or Favipiravir. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, non-randomized clinical trial study. The number of 40 COVID-19 patients with moderate severity will be admitted in progressive care units (PCUs) and intensive care units (ICUs) enrolled in the study. The sampling will be purposive and based on the same independent variables, including age, gender, past medical histories, and the situation of the patient at the admission day, and ventilator support. The patients will be allocated into two groups with different regimens. Group "A" (regimen A)will be defined as Favipiravir 1600 mg a first dose and 600 mg in 3 divided doses daily plus 400 mg in 2 divided doses of Hydroxychloroquine every day. The group "B" (regimen B) will be contained 400 mg of Lopinavir/Ritonavirin 2 divided doses plus the first dose (400 mg) of Hydroxychloroquine. Hydroxychloroquine will not be used for adverse drug reactions. The regimen remained at least 7 up to 10 days. Data will be analyzed using statistical package for social sciences (SPSS) version 18 (SPSS Inc. Chicago, IL, USA) for windows. The variables will be compared using independent and paired T-test for normally distributed variables and Wilcoxon, Chi-square for non-normal distributed variables. The Kaplan Meier test will be used for survival analysis and the one-sample Kolmogorov-Smirnov test for the evaluation of distributions.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Role of Lopinavir/Ritonavir in the Treatment of Covid-19: A Review of Current Evidence, Guideline Recommendations, and Perspectives.
Meini S, Pagotto A, Longo B, Vendramin I, et al · · 2020 · cited 52× · PMID 32629768 · DOI 10.3390/jcm9072050 -
Tackling COVID-19 Using Remdesivir and Favipiravir as Therapeutic Options.
Sreekanth Reddy O, Lai WF. · · 2021 · cited 39× · PMID 33031623 · DOI 10.1002/cbic.202000595 -
Novel therapeutic approaches for treatment of COVID-19.
Hossein-Khannazer N, Shokoohian B, Shpichka A, Aghdaei HA, et al · · 2020 · cited 36× · PMID 32494931 · DOI 10.1007/s00109-020-01927-6 -
COVID-19: An overview of the current pharmacological interventions, vaccines, and clinical trials.
Chakraborty R, Parvez S. · · 2020 · cited 35× · PMID 32739342 · DOI 10.1016/j.bcp.2020.114184 -
The recent outbreaks of human coronaviruses: A medicinal chemistry perspective.
Pillaiyar T, Wendt LL, Manickam M, Easwaran M. · · 2021 · cited 32× · PMID 32852058 · DOI 10.1002/med.21724 -
The Rationale for Potential Pharmacotherapy of COVID-19.
Saber-Ayad M, Saleh MA, Abu-Gharbieh E. · · 2020 · cited 30× · PMID 32423024 · DOI 10.3390/ph13050096 -
The controversial therapeutic journey of chloroquine and hydroxychloroquine in the battle against SARS-CoV-2: A comprehensive review.
Das S, Ramachandran AK, Birangal SR, Akbar S, et al · · 2021 · cited 22× · PMID 33846702 · DOI 10.1016/j.medidd.2021.100085
Verify or expand the search:
- PubMed search for NCT04376814
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04376814 (US National Library of Medicine, public domain)
- 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 Baqiyatallah Medical Sciences University
- Last refreshed: 16 June 2020
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/NCT04376814.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing