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NCT04376814

Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19

Completed NA Last updated 16 June 2020
What this trial tests

NA trial testing Favipiravir in COVID-19 in 40 participants. Completed in 25 May 2020.

Timeline
29 March 2020
Primary endpoint
5 April 2020
25 May 2020

Quick facts

Lead sponsorBaqiyatallah Medical Sciences University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date29 March 2020
Primary completion5 April 2020
Estimated completion25 May 2020
Sites1 location across Iran

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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:

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