CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

CD24FcWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug1535 MySafeRx Inspire Flex Wiki 1.00
drug1536 MySafeRx Inspire Plus Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment

The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID 19. Arm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. All subjects will be treated with the best available treatment. The follow up period is 28 days.

NCT04317040 Severe Coronavirus Disease (COVID-19) Drug: CD24Fc Drug: Placebo
MeSH:Coronavirus Infections

Primary Outcomes

Description: Time to improve in clinical status: the time (days) required from the start of treatment to the improvement of clinical status "severe" to "moderate/mild"; or improvement from "scale 3 or 4" to "scale 5 or higher" based on NIAID ordinal scales.

Measure: Improvement of COVID-19 disease status

Time: 29 days

Secondary Outcomes

Description: Proportion of patients who died or had respiratory failure, defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high flow oxygen devices, at Day 29

Measure: Proportion of patients who died or had respiratory failure.

Time: 29 days

Description: Time for disease progression from NIAID scale 3 or 4 to need to be on invasive mechanical ventilation, or ESMO, or death.

Measure: Disease progression of COVID-19

Time: 29 days

Description: All cause of death

Measure: All cause of death

Time: 29 days

Description: Proportion of clinical relapse, as defined by rate of return to oxygen support for more than 1 day within 29 days from randomization after initial recovery

Measure: Proportion of clinical relapse

Time: 29 days

Description: Conversion rate of clinical status on days 8 (proportion of subjects who changed from NIAID ordinal "scale 3 or 4" to "scale 5 or higher")

Measure: Conversion rate of clinical status at Day 8

Time: 8 days

Description: Conversion rate of clinical status on days 15 (proportion of subjects who changed from NIAID ordinal "scale 3 or 4" to "scale 5 or higher")

Measure: Conversion rate of clinical status at Day 15

Time: 15 days

Description: The discharge time, calculated after the randomization.

Measure: Hospital discharge time

Time: 29 days

Description: Duration of mechanical ventilation (IMV, NIV) (days)

Measure: Duration of mechanical ventilation

Time: 29 days

Description: Duration of pressors (days)

Measure: Duration of pressors

Time: 29 days

Description: Duration of extracorporeal membrane oxygenation (days)

Measure: Duration of ECMO

Time: 29 days

Description: Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days)

Measure: Duration of high flow oxygen therapy

Time: 29 days

Description: Changes of absolute lymphocyte count in peripheral blood

Measure: Absolute lymphocyte count

Time: 29 days

Description: The changes of plasma concentration of D-dimers

Measure: Change of D-dimers

Time: 15 and 29 days

No related HPO nodes (Using clinical trials)