The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID)

NCT04405739 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EIDD-2801-2004
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 11

Brief Summary

Designed as a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults with polymerase chain reaction (PCR)-Confirmed COVID-19.

Conditions

SARS-CoV 2

Outcome Measures

Primary Outcomes (3)

• Number of Participants That Achieve Virologic Clearance After Oral Administration of EIDD-2801

  Achievement of undetectable (below the limit of detection of the assay) SARS-CoV-2 RNA by day 5 in NP swabs by quantitative Polymerase Chain Reaction (qPCR) in the Efficacy Analysis Set (EAS). The Efficacy Analysis Set consisted of all participants treated with at least on dose of study drug and with at least 1 post baseline assessment of SARS-CoV-2 RNA in NP swabs by qPCR

  28 days

• Number of Participants With Any Serious Adverse Events(SAEs) as Assessed by DAIDS

  Incidence of Serious Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS in the Safety Population, defined as all participants treated with at least one dose of study drug.

  28 days

• Number of Participants With Any Adverse Events(AEs) as Assessed by DAIDS

  Incidence of Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS

  28 days

Study Arms (2)

EIDD-2801 twice daily (BID) for 5 days

EXPERIMENTAL

EIDD-2801 orally twice daily (BID) for 5 days at Dose A, Dose B, Dose C, Dose D, Dose E, Dose F

Drug: EIDD-2801

placebo (PBO) twice daily (BID) for 5 days

PLACEBO COMPARATOR

Placebo (PBO) orally twice daily (BID) for 5 days matched for size and appearance to active IP

Drug: Placebo

Interventions

EIDD-2801 DRUG

Oral capsule of EIDD-2801

Also known as: molnupiravir, MK-4482

EIDD-2801 twice daily (BID) for 5 days

Placebo DRUG

Oral placebo capsule

Also known as: PBO

placebo (PBO) twice daily (BID) for 5 days

Eligibility Criteria

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

You may qualify if:

• Has COVID-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days):
• Fevers OR
• At least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia OR
• Anosmia OR
• other clinical symptoms or signs of COVID-19 that are not otherwise explained by comorbidities or co-diagnoses
• PCR+ test for SARS-CoV-2.
• Has new signs or symptoms of COVID-19 that began ≤7 days of anticipated first dose of study drug.
• Persons ≥18 years old.
• at the time of first dose.
• \. ≥18 years old.
• \. Is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (SOC).
• \. Is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study drug.
• Pregnancy and Contraception: In nonclinical developmental and reproductive toxicity studies, developmental toxicity including malformation was observed in fetuses from pregnant animals dosed with EIDD-2801 (MK 4482). Therefore, treatment with EIDD-2801 is contraindicated in women who are pregnant or nursing and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during the study and for 4 days after completion of EIDD 2801 dosing in female participants and for 4 days after completion of EIDD-2801 dosing in female partners of male participants.
• \. A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP) OR

You may not qualify if:

• Is anticipated to require ICU admission for mechanical ventilation within 24 hours of enrollment.
• Requires more than 6 liters/minute of oxygen to maintain O2 saturation above 95%
• Is not expected to survive longer than 24 hours.
• Has a platelet count less than 100,000/µL, hemoglobin less than 9 g/dL, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease.
• Women who are pregnant or breastfeeding.
• Is experiencing DAIDS AE grading scale grade 4 baseline medical conditions or laboratory abnormalities..
• Has received a vaccine for COVID-19 prior to enrollment, or plans to receive a vaccine for COVID-19 before the end-of-study visit.
• Has received an experimental antiviral treatment for COVID-19 prior to enrollment.
• Has received convalescent plasma or other monoclonal antibodies prior to enrollment..
• Is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted).
• In the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (GFR) \<30 mL/min by the Modification of Diet in Renal Disease (MDRD) study equation prior to COVID-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease prior to COVID-19 symptom onset requiring bilevel positive airway pressure (BiPAP) or \>4 L/min supplemental oxygen at baseline; if using ≤4 L/min supplemental oxygen at baseline, consultation with and approval of the sponsor is required prior to enrollment.
• Has a diagnosis of cancer that is not in remission. Noninvasive cancers, such as basal and squamous cell carcinoma or history of in situ tumors are allowed at the discretion of the investigator after discussion with the sponsor.
• Has received an organ transplantation.
• Has received a bone marrow transplantation.
• Has been on immunosuppressive medications within one month prior to enrollment.

Sponsors & Collaborators

• Ridgeback Biotherapeutics, LP: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (11)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095-8358, United States

Location

Cook County Hospital

Chicago, Illinois, 60612, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Ochsner LSU Health Shreveport Academic Medical Center

Shreveport, Louisiana, 71101, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

John Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Howard County General Hospital

Columbia, Maryland, 21044, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Cox RM, Wolf JD, Plemper RK. Therapeutically administered ribonucleoside analogue MK-4482/EIDD-2801 blocks SARS-CoV-2 transmission in ferrets. Nat Microbiol. 2021 Jan;6(1):11-18. doi: 10.1038/s41564-020-00835-2. Epub 2020 Dec 3.

  PMID: 33273742 DERIVED

MeSH Terms

Interventions

molnupiravir

Results Point of Contact

• Title: Wendy Painter, MD, MPH
• Organization: Ridgeback Biotherapeutics

EIDD2801@ridgebackbio.com

786-687-2495

Study Officials

• Ashwin Balagopal, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 28, 2020
• Study Start: June 16, 2020
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: March 23, 2023
• Results First Posted: March 23, 2023

Record last verified: 2023-03

Locations

US (11)