CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Blood and derivatives.Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug2319 Standard of Care Wiki 0.20

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D000856 Anorexia Nervosa NIH 1.00
D000855 Anorexia NIH 1.00

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002039 Anorexia HPO 1.00

There is one clinical trial.

Clinical Trials

1 Multi-center, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients

A total of 278 patients are planned. All patients will be in an early-stage of COVID-19. They must be adults and hospitalized. In this study, all participating patients will receive the standard treatment provided according to the current treatment protocols for coronavirus disease. In addition to this treatment, each patient will be randomly assigned to receive additional treatment with convalescent plasma transfusion (CP; blood plasma from patients who have been cured of coronavirus), or continue with standard treatment but without adding transfusion. 50% of the chances of additional treatment with CP, and 50% of the chances of receiving only the standard treatment for coronavirus. The duration of the study shall be one month from the assignment of the treatment. The patient and the doctor will know the treatment assigned.

NCT04345523 COVID-19 Other: Blood and derivatives. Drug: Standard of Care

Primary Outcomes

Description: Proportion of patients in categories 5, 6 or 7 of the 7-point ordinal scale at day 15 Ordinal scale: Not hospitalized, no limitations on activities. Not hospitalized, limitation on activities. Hospitalized, not requiring supplemental oxygen. Hospitalized, requiring supplemental oxygen. Hospitalized, on non-invasive ventilation or high flow oxygen devices. Hospitalized, on invasive mechanical ventilation or ECMO. Death.

Measure: Category Changes in Ordinal Scale

Time: 15 days

Secondary Outcomes

Description: Time to change from baseline category to worsening into 5,6 or 7 categories of the ordinal scale

Measure: Time to category 5, 6 or 7 of the ordinal scale

Time: 29 days

Description: Mortality

Measure: Mortality of any cause at 15 days

Time: 15 days

Description: Mortality

Measure: Mortality of any cause at 29 days

Time: 29 days

Description: days free from oxygen supplementation

Measure: Oxygenation free days

Time: 29 days

Description: days free from mechanical ventilation

Measure: Ventilator free days

Time: 29 days

Description: Infusion-related adverse events Cumulative incidence of serious adverse events (SAEs) Cumulative incidence of Grade 3 and 4 adverse events (AEs).

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 29 days

Description: Quantitative total antibodies and neutralizing antibody activity against SARSCoV-2 in the sera from donors and patients using viral pseudotypes

Measure: Antibodies levels in CP donors recovered from COVID-19

Time: 3 months

Description: Change in PCR for SARS-CoV-2 in naso/oropharyngeal swabs and blood at baseline and on days 3, 5, 8, 11 (while hospitalized); and days 15 and 29 (if able to return to clinic or still hospitalized).

Measure: Viral load

Time: Days 1,3,5,8,11 and 29

Other Outcomes

Description: Serum levels of CRP, lymphocyte count, LDH, D Dimer,IL-6, coagulation tests at baseline and days 3, 5, 8, 11, 15 and 29.

Measure: Change in biological parameters

Time: Days 1,3,5,8,11 and 29

No related HPO nodes (Using clinical trials)