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200 mg EIDD-2801Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (10)

Name (Synonyms) Correlation
drug1824 Placebo (PBO) Wiki 0.71
drug239 Atorvastatin 40mg Wiki 0.71
drug35 300 mg EIDD-2801 Wiki 0.71
drug2106 Rivaroxaban 2.5 MG Wiki 0.71
drug1679 Omeprazole 20mg Wiki 0.71
drug1101 Hydroxychloroquine Pre-Exposure Prophylaxis Wiki 0.71
drug589 Clopidogrel 75mg Wiki 0.71
drug219 Aspirin 75mg Wiki 0.71
drug1853 Placebo oral tablet Wiki 0.13
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D054058 Acute Coronary Syndrome NIH 0.41
D003141 Communicable Diseases NIH 0.06
D007239 Infection NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials

1 A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate Infectious Virus Detection in Persons With COVID-19

This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19

NCT04405570 SARS-CoV 2 Drug: 200 mg EIDD-2801 Drug: Placebo
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding stratified log-rank test (to account for the "early" versus "late" time from symptom onset randomization strata)

Measure: Virologic Efficacy

Time: 28 days

Description: Measure the safety and tolerability of EIDD-2801 by estimating in the randomization arm the probability of 1) any adverse events (AEs) leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AE (not already present at baseline), and 4) study drug-related new grade 3 or higher AE. The cumulative probability of each safety and each tolerability endpoint (4 endpoints) by using the Kaplan-Meier approach and stratified log-rank test.

Measure: Number of Participants with any Adverse Events (AEs) as Assessed by Kaplan Meier Approach

Time: 28 days

Secondary Outcomes

Description: Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs by using the Kaplan-Meier approach and stratified log-rank test.

Measure: Number of Participants With any Adverse Events (AEs), Grade 2 or higher as Assessed by Kaplan Meier Approach

Time: 28 days

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

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.

NCT04405739 SARS-CoV 2 Drug: 200 mg EIDD-2801 Drug: 300 mg EIDD-2801 Drug: Placebo (PBO)

Primary Outcomes

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

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

Time: 28 days

Description: Incidence of Serious Adverse Events in subjects receiving EIDD-2801

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

Time: 28 days

Description: Incidence of Adverse Events in subjects receiving EIDD-2801

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

Time: 28 days

No related HPO nodes (Using clinical trials)