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The Safety of EIDD-2801 and Its Effect on Viral Shedding of SARS-CoV-2

Trial Profile

The Safety of EIDD-2801 and Its Effect on Viral Shedding of SARS-CoV-2

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 21 May 2021

At a glance

  • Drugs Molnupiravir (Primary)
  • Indications COVID-19 respiratory infection
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms END-COVID
  • Sponsors Ridgeback Biotherapeutics
  • Most Recent Events

    • 18 May 2021 Planned number of patients changed from 80 to 96.
    • 18 May 2021 Planned End Date changed from 28 May 2021 to 8 Dec 2021.
    • 18 May 2021 Planned primary completion date changed from 28 May 2021 to 16 Aug 2021.

Trial Overview

Purpose

Designed as a single 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.

Primary Endpoints

Number of Participants that achieve Virologic Clearance after oral administration of EIDD-2801

description: Achievement of undetectable SARS-CoV-2 RNA by Day 5 in nasopharyngeal (NP) swabs by quantitative reverse transcription polymerase chain reaction (qPCR) after administration with EIDD-2801
time_frame: 28 days

Number of Participants With any Serious Adverse Events(SAEs) as assessed by DAIDS

description: Incidence of Serious Adverse Events in subjects receiving EIDD-2801
time_frame: 28 days

Number of Participants With any Adverse Events(AEs) as assessed by DAIDS

description: Incidence of Adverse Events in subjects receiving EIDD-2801
time_frame: 28 days

Diseases Treated

Indication Qualifiers Patient Segments
COVID-19 respiratory infection treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 96

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion Criteria

1. 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 2. PCR+ test for SARS-CoV-2. 3. Has new signs or symptoms of COVID-19 that began ≤7 days of anticipated first dose of study drug. 4. Persons ≥18 years old. 5. Is admitted and is anticipated to remain in the hospital for ≥ 24 hours. 6. 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). 7. Is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent. Pregnancy and Contraception: 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. 8. 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 - Is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user-dependent method in combination with a barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 2 during the intervention period and for at least 4 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. - A WOCBP must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention. - The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. - Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Given the elevated risk of venous thrombotic events in patients hospitalized with COVID 19 (Benson et al 2020; Spratt et al 2020), estrogen-containing contraceptives must not be started to fulfill the contraceptive requirement of this study at any time during participant's hospitalization. If contraceptives are interrupted as standard of care management of COVID-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. 9. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR - Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration. • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Patient Exclusion Criteria

1. Is anticipated to require ICU admission for mechanical ventilation within 24 hours of enrollment. 2. Requires more than 6 liters/minute of oxygen to maintain O2 saturation above 95% 3. Is not expected to survive longer than 24 hours. 4. 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. 5. Women who are pregnant or breastfeeding. 6. Is experiencing DAIDS AE grading scale grade 4 baseline medical conditions or laboratory abnormalities.. 7. 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. 8. Has received an experimental antiviral treatment for COVID-19 prior to enrollment. 9. Has received convalescent plasma or other monoclonal antibodies prior to enrollment.. 10. 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). 11. 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. 12. 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. 13. Has received an organ transplantation. 14. Has received a bone marrow transplantation. 15. Has been on immunosuppressive medications within one month prior to enrollment. 16. Has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial. 17. Has known active hepatitis C (HCV RNA positive), active hepatitis B (hepatitis B surface antigen positive), or HIV (ELISA and confirmatory Western blotting). New screening tests not required. 18. Is currently taking nucleos(t)ide analogues for HIV or Hepatitis B, or for their prevention, within 30 days of study enrollment. 19. Is currently taking systemic corticosteroids other than replacement doses, or for treatment of COVID-19. 20. Has a Body Mass Index (BMI) >50 kg/m2. 21. Is anticipated to require surgery within 48 hours after hospital admission. 22. Is anticipated to have a nothing per mouth (NPO) order placed within 48 hours after hospital admission that is expected to last for > 24 hours.

Trial Details

Identifiers

Identifier Owner
NCT04405739 ClinicalTrials.gov: US National Institutes of Health
EIDD2801-2004 -

Organisations

  • Sponsors Ridgeback Biotherapeutics
  • Affiliations Ridgeback Biotherapeutics

Trial Dates

  • Initiation Dates

    Planned : 01 Jun 2020

    Actual : 16 Jun 2020

  • Primary Completion Dates

    Planned : 16 Aug 2021

  • End Dates

    Planned : 08 Dec 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location USA
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
MolnupiravirPrimary Drug Oral Capsule

EIDD-2801 twice daily (BID) for 5 days

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 (Oral capsule of EIDD-2801) Other Name: molnupiravir, MK-4482

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

Placebo (PBO) orally twice daily (BID) for 5 days matched for size and appearance to active IP Drug: Placebo (Oral placebo capsule) Other Name: PBO

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Adam Treitman, MD
847-723-8200
show details
Advocate Christ Medical Center USA
Ashwan Balagopal Johns Hopkins Bayview Medical Center USA
Ashwin Balagopal Howard County General Hospital, John Hopkins Hospital, Suburban Hospital USA
Caryn Morse, MD Wake Forest Baptist Health USA
Chen "Anna" Zheng
310-794-0129 czheng@mednet.ucla.edu
show details
Ronald Reagan UCLA Medical Center USA
Debika Bhattacharya, MD Ronald Reagan UCLA Medical Center USA
Elizabeth Zieser-Misenheimer
ezeiserm@wakehealth.com
show details
Wake Forest Baptist Health USA
Krystin Nieto
713-441-3192
show details
Houston Methodist Hospital USA
Laura Szewczyk
786-687-2495 EIDD2801@ridgebackbio.com
show details
-
Mathew Itteera
312-864-4606
show details
Cook County Hospital USA
Stephanie Swords
sswords1@jhmi.edu
show details
Howard County General Hospital, John Hopkins Hospital, Johns Hopkins Bayview Medical Center, Suburban Hospital USA
Todd Rice, MD Vanderbilt University USA

Centres

Centre Name Location Trial Centre Country
-
-
-
Advocate Christ Medical Center Oak Lawn, Illinois USA
Advocate Christ Medical Center Park Ridge, Illinois USA
Cook County Hospital Chicago, Illinois USA
Houston Methodist Hospital Houston, Texas USA
Howard County General Hospital Columbia, Maryland USA
John Hopkins Hospital Baltimore, Maryland USA
Johns Hopkins Bayview Medical Center Baltimore, Maryland USA
Ridgeback Biotherapeutics
-
-
Ronald Reagan UCLA Medical Center Los Angeles, California USA
Suburban Hospital Bethesda, Maryland USA
Vanderbilt University Nashville, Tennessee USA
Wake Forest Baptist Health Winston-Salem, North Carolina USA

Trial History

Event Date Event Type Comment
21 May 2021 Other trial event Last checked against ClinicalTrials.gov record. Updated 21 May 2021
18 May 2021 Other trial event Planned number of patients changed from 80 to 96. Updated 21 May 2021
18 May 2021 Completion date Planned End Date changed from 28 May 2021 to 8 Dec 2021. Updated 21 May 2021
18 May 2021 Other trial event Planned primary completion date changed from 28 May 2021 to 16 Aug 2021. Updated 21 May 2021
17 Feb 2021 Completion date Planned End Date changed from 12 Mar 2021 to 28 May 2021. Updated 23 Feb 2021
17 Feb 2021 Other trial event Planned primary completion date changed from 12 Feb 2021 to 28 May 2021. Updated 23 Feb 2021
08 Dec 2020 Other trial event Planned number of patients changed from 89 to 80. Updated 16 Dec 2020
08 Dec 2020 Completion date Planned End Date changed from 25 Nov 2020 to 12 Mar 2021. Updated 16 Dec 2020
08 Dec 2020 Other trial event Planned primary completion date changed from 28 Oct 2020 to 12 Feb 2021. Updated 16 Dec 2020
10 Sep 2020 Protocol amendment The study design is changed from single-centre to multi-centre and the number of arms is decreased from 3 to 2, removing the 300 mg arm and adding up 5 different doses to a single-arm. Estimated enrolment is increased from 60 to 89. Updated 21 Sep 2020
10 Sep 2020 Other trial event Planned number of patients changed from 60 to 89. Updated 21 Sep 2020
10 Sep 2020 Completion date Planned End Date changed from 1 Sep 2020 to 25 Nov 2020. Updated 21 Sep 2020
10 Sep 2020 Other trial event Planned primary completion date changed from 1 Aug 2020 to 28 Oct 2020. Updated 21 Sep 2020
16 Jun 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 22 Jun 2020
01 Jun 2020 Other trial event Planned number of patients changed from 80 to 60. Updated 05 Jun 2020
01 Jun 2020 Completion date Planned End Date changed from 13 Jul 2020 to 1 Sep 2020. Updated 05 Jun 2020
01 Jun 2020 Other trial event Planned primary completion date changed from 24 Jun 2020 to 1 Aug 2020. Updated 05 Jun 2020
01 Jun 2020 Other trial event Planned initiation date changed from 26 May 2020 to 1 Jun 2020. Updated 05 Jun 2020
29 May 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04405739). Updated 29 May 2020
26 May 2020 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 29 May 2020
07 Apr 2020 Other trial event According to a Ridgeback Biotherapeutics media release, U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application for EIDD-2801 Updated 08 Apr 2020
02 Apr 2020 Other trial event According to a Ridgeback Biotherapeutics media release, the company expects to begin this human trial for EIDD-2801 in April 2020. Updated 03 Apr 2020
24 Mar 2020 New trial record New trial record Updated 24 Mar 2020
19 Mar 2020 Other trial event According to a Ridgeback Biotherapeutics media release, this trial is expected to begin in second half of 2020. Updated 24 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  2. Ridgeback Biotherapeutics. Ridgeback Biotherapeutics and Drug Innovations Ventures at Emory Partner to Develop Clinical Stage Coronavirus Treatment. Media-Rel 2020;.

    Media Release
  3. Ridgeback Biotherapeutics. Breakthrough Ebola Treatment Receives Contract from U.S. Government. Media-Rel 2020;.

    Media Release
  4. Ridgeback Biotherapeutics. FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19. Media-Rel 2020;.

    Media Release
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