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

• ClinicalTrials.gov Identifier: NCT04346628
• Recruitment Status: Enrolling by invitation
• First Posted: April 15, 2020
• Last Update Posted: October 5, 2020
• Sponsor: Stanford University
• Information provided by (Responsible Party): Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sars-CoV2; COVID-19	Drug: Favipiravir; Drug: Placebo; Other: Standard of care treatment	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19
• Actual Study Start Date: July 12, 2020
• Estimated Primary Completion Date: July 2021
• Estimated Study Completion Date: July 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Favipiravir; In addition to SOC, participants will receive favipiravir for 10 days, and be evaluated for health outcomes through day 28.	Drug: Favipiravir; 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).; Other: Standard of care treatment; Standard of care treatment for COVID-19 infection
Active Comparator: Placebo; 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; Placebo to match favipiravir administered orally through day 10.; Other: Standard of care treatment; Standard of care treatment for COVID-19 infection

Outcome Measures

Primary Outcome Measures :

1. Time until cessation of oral shedding of SARS-CoV-2 virus [ Time Frame: Up to 28 days ]
   Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.

Secondary Outcome Measures :

1. Sars-CoV-2 viral load [ Time Frame: Up to 28 days ]
   Viral load (nucleic acid) will be assessed by RT-PCR over time.
2. Count of participants with clinical worsening of COVID-19 disease [ Time Frame: Up to 28 days ]
   Clinical worsening will be determined by clinician assessment.
3. Count of participants with development of SARS-CoV-2 antibodies [ Time Frame: Up to 28 days ]
4. Time until cessation of symptoms [ Time Frame: Up to 28 days ]
5. Count of participant with absence of development of any symptoms [ Time Frame: Up to 28 days ]
   This outcome will be assessed in patient who are asymptomatic of COVID-19 infection at the time of enrollment
6. Cmax of favipiravir [ Time Frame: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration) ]
   Cmax is a pharmacokinetic parameter that measures the maximum concentration of drug in plasma.
7. Cmin of favipiravir [ Time Frame: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration) ]
   Cmin is a pharmacokinetic parameter that measures the minimum concentration of drug in plasma.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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
• Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met
• 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

Exclusion Criteria:

• 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.
• Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
• Taken another investigational drug within the past 30 days.
• Seemed by the Investigator to be ineligible for any reason.

Contacts and Locations

Locations

United States, California

Stanford University

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Yvonne (Bonnie) A Maldonado, MD; Stanford University

More Information

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT04346628
• Other Study ID Numbers: 56032
• First Posted: April 15, 2020
• Last Update Posted: October 5, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No current plan to share individual participant data (IPD).

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No