Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19

NCT04346628 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 56032
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19.

Conditions

Sars-CoV2; COVID-19

Outcome Measures

Primary Outcomes (1)

• Time Until Cessation of Oral Shedding of SARS-CoV-2 Virus

  Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.

  Up to 28 days

Secondary Outcomes (7)

• Sars-CoV-2 Viral Load

  Up to 28 days

• Count of Participants With Clinical Worsening of COVID-19 Disease

  Up to 28 days

• Count of Participants With Development of SARS-CoV-2 Antibodies

  Up to 28 days

• Time Until Cessation of Symptoms

  Up to 28 days

• Count of Participant With Absence of Development of Any Symptoms

  Up to 28 days

Study Arms (2)

Favipiravir

EXPERIMENTAL

In addition to SOC, participants will receive favipiravir for 10 days, and be evaluated for health outcomes through day 28.

Drug: Favipiravir; Other: Standard of care treatment

Placebo

ACTIVE COMPARATOR

In addition to SOC, participants will receive placebo to match favipiravir for 10 days, and be evaluated for health outcomes through day 28.

Drug: Placebo; Other: Standard of care treatment

Interventions

Favipiravir DRUG

Favipiravir administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).

Favipiravir

Placebo DRUG

Placebo to match favipiravir administered orally through day 10.

Placebo

Standard of care treatment OTHER

Standard of care treatment for COVID-19 infection

Favipiravir; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COVID-19 disease:
• If symptomatic, presence of mild to moderate symptoms without signs of respiratory distress, with positive for SARS-CoV-2 diagnostic assay within 72 hours prior to.informed consent.
• If asymptomatic, initial diagnosis obtained no more than 72 hours prior to informed consent
• Subject agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol

You may not qualify if:

• Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
• Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
• Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy
• Females must have a negative pregnancy test at screening
• Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol
• Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding).
• History of abnormal uric acid metabolism.
• History of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.
• Abnormal laboratory test results at screening:
• Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.
• Serious chronic disease (e.g., human immunodeficiency virus \[HIV\], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
• Previously received favipiravir within the past 30 days.
• Advanced kidney disease
• Advanced liver disease
• History of alcohol or drug abuse in the previous two years.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• Holubar M, Subramanian A, Purington N, Hedlin H, Bunning B, Walter KS, Bonilla H, Boumis A, Chen M, Clinton K, Dewhurst L, Epstein C, Jagannathan P, Kaszynski RH, Panu L, Parsonnet J, Ponder EL, Quintero O, Sefton E, Singh U, Soberanis L, Truong H, Andrews JR, Desai M, Khosla C, Maldonado Y. Favipiravir for Treatment of Outpatients With Asymptomatic or Uncomplicated Coronavirus Disease 2019: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial. Clin Infect Dis. 2022 Nov 30;75(11):1883-1892. doi: 10.1093/cid/ciac312.

  PMID: 35446944 RESULT

• Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.

  PMID: 33624010 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Yvonne A. Maldonado, MD
• Organization: Stanford University

bonniem@stanford.edu

(650) 723-5682

Study Officials

• Yvonne (Bonnie) A Maldonado, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: July 12, 2020
• Primary Completion: April 16, 2021
• Study Completion: April 16, 2021
• Last Updated: July 13, 2022
• Results First Posted: April 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)