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

  • STATUS
    Recruiting
  • days left to enroll
    43
  • participants needed
    80
  • sponsor
    Ridgeback Biotherapeutics, LP
Updated on 1 March 2021
Investigator
Laura Szewczyk
Primary Contact
John Hopkins Hospital (7.7 mi away) Contact
+11 other location
pneumonia
fever
estrogen
dyspnea
SARS
PCR test
cough
anosmia

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.

Description

Phase 2a randomized, placebo-controlled, double-blinded clinical trial of EIDD-2801 in adult men and women who have tested positive for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection within 144 hours of polymerase chain reaction (PCR) confirmation and are hospitalized with a diagnosis of COVID-19. Rapid enrollment and treatment will be initiated such that the first dose of EIDD-2801 or placebo will be administered as soon as possible and within 7 days of onset of symptoms.

Details
Condition SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, Sars Cov 2
Treatment EIDD-2801, 200 mg EIDD-2801, 300 mg EIDD-2801, Placebo (PBO), Placebo (PB0)
Clinical Study IdentifierNCT04405739
SponsorRidgeback Biotherapeutics, LP
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have SARS-CoV 2?
Do you have any of these conditions: SARS-CoV 2 or Sars Cov 2?
Do you have any of these conditions: SARS-CoV 2 or Sars Cov 2?
Do you have any of these conditions: Sars Cov 2 or SARS-CoV 2?
Do you have any of these conditions: Sars Cov 2 or SARS-CoV 2?
Do you have any of these conditions: Sars Cov 2 or SARS-CoV 2?
Do you have any of these conditions: SARS-CoV 2 or Sars Cov 2?
Do you have any of these conditions: SARS-CoV 2 or Sars Cov 2?
Do you have any of these conditions: Sars Cov 2 or SARS-CoV 2?
Do you have any of these conditions: SARS-CoV 2 or Sars Cov 2?
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
Is admitted and is anticipated to remain in the hospital for 24 hours
Pregnancy and Contraception: Treatment with EIDD-2801 is contraindicated in
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)
women who are pregnant or nursing and in the male partners of women who are
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
pregnant. Extreme care must be taken to avoid pregnancy during the study and
for 50 days after completion of EIDD 2801 dosing in female participants and
for 100 days after completion of EIDD-2801 dosing in female partners of male
participants
Have a negative serum pregnancy test at Screening
\. Female participants of childbearing potential must meet the the following
criteria to be enrolled
Must agree to undergo a follow-up pregnancy test on Study Day 28
Must agree to use at least 2 forms of contraception during the study and for at least 50 days after dosing of the study drug is complete, as discussed with and approved by the investigator
OR Must have an azoospermic partner (vasectomized or due to a to medical
cause) Note: azoospermic partner is acceptable provided that the partner is
the sole sexual partner of the woman of childbearing potential and the absence
of sperm has been confirmed
Note that female not of childbearing potential is defined as either
i. Surgically sterile: females who are permanently sterile via hysterectomy
bilateral salpingectomy, and/or bilateral oophorectomy by reported medical
history and/or medical records. Surgical sterilization to have occurred a
minimum of 6 weeks, or at the Investigator's discretion, prior to Screening
OR
ii. Postmenopausal: Females at least 60 years of age with amenorrhea for 12
months (by history) or 45 years of age with amenorrhea for 12 months without
an alternative medical reason with confirmatory follicle stimulating hormone
levels of 40 mIU/mL. The amenorrhea should not be induced by a medical
condition such as anorexia nervosa, hypothyroid disease or polycystic ovarian
disease, or by extreme exercise. It should not be due to concomitant
medications that may have induced the amenorrhea such as oral contraceptives
hormones, gonadotropin releasing hormones, anti-estrogens, or selective
estrogen receptor modulators
\. Male participants must refrain from donating sperm during the study and
for 100 days after dosing of the study drug is complete
\. Male participants with female partners must have either
Surgical sterilization (vasectomy 1 month before screening) OR
Female partner must be of not be of childbearing potential OR
Agree to use 2 forms of contraception during the study and for 100 days after dosing of the study drug is complete, as discussed with and approved by the investigator

Exclusion Criteria

Requires more than 6 liters/minute of oxygen to maintain O2 saturation above 95%
Has an illness within the past 30 days that requires mechanical ventilation prior to enrollment
Is anticipated to require ICU admission for mechanical ventilation within 24 hours of enrollment
Is not expected to survive longer than 24 hours
Has a platelet count less than 100,000/L, hemoglobin less than 10 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
Has received an experimental vaccine for COVID-19 prior to the first dose of study drug
Is experiencing DAIDS AE grading scale grade 4 baseline medical conditions or laboratory abnormalities
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 >2 L/min supplemental oxygen at baseline; if using 2 L/min supplemental oxygen at baseline, consultation with and approval of the sponsor is required prior to enrollment
Has received hydroxychloroquine or chloroquine within 30 days of study 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
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)
Has received an organ transplantation
Has received a bone marrow transplantation
Has been on immunosuppressive medications within one month prior to enrollment
Has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial
Is currently taking systemic corticosteroids other than replacement doses, or for treatment of COVID-19
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
Has a Body Mass Index (BMI) >50 kg/m2
Is currently taking nucleos(t)ide analogues for HIV or Hepatitis B, or for their prevention, within 30 days of study enrollment
Is anticipated to require surgery within 48 hours after hospital admission
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
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