CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Pacebo: Calcium citrateWiki

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


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug841 There is no intervention in this study Wiki 1.00
drug361 Hydroxychloroquine (HCQ) Wiki 0.58

Correlated MeSH Terms (6)


Name (Synonyms) Correlation
D003333 Coronaviridae Infections NIH 0.58
D003141 Communicable Diseases NIH 0.12
D014777 Virus Diseases NIH 0.11
D007239 Infection NIH 0.08
D045169 Severe Acute Respiratory Syndrome NIH 0.07
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Treating COVID-19 With Hydroxychloroquine: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial in Hospitalized Adults

Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial will determine if HCQ is effective as treatment in hospitalized non-ICU patients with COVID-19.

NCT04369742 COVID-19 Drug: Hydroxychloroquine (HCQ) Other: Pacebo: Calcium citrate

Primary Outcomes

Measure: Cumulative incidence of SAEs through day 30

Time: 30 days

Measure: Cumulative incidence of grade 3 or 4 AEs through day 30

Time: 30 days

Measure: Incidence of discontinuation of therapy (for any reason)

Time: 30 days

Description: Including any of the following: mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support by the 14-day post-treatment evaluation (PTE)

Measure: Severe disease progression composite outcome

Time: 14 days

Secondary Outcomes

Description: Events = mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support

Measure: Cumulative incidence of events

Time: 30 days

Description: LOS is defined as the interval (in days) that the patient was admitted to a non-rehabilitation floor, categorized as short (<7 days), moderate (7-10 days), or extended (>10 days)

Measure: Hospital length of stay

Time: 30 days

Description: Defined as number of days with temperature >100.4 degrees Fahrenheit.

Measure: Days of fever

Time: 14 days

Description: Defined as days the patient is placed on non-invasive ventilator support (CPAP or BiPAP), excluding routine CPAP use for sleep apnea.

Measure: Days of non-invasive ventilator use

Time: 14 days

Description: Defined as the number of days the subject was on a non-rebreather mask.

Measure: Days of non-rebreather mask oxygen supplementation

Time: 14 days

Description: Grade 1 (mild) = able to be managed with nonparenteral supportive care, Grade 2 (moderate) = at least one of the following present (hospitalization needed for management of CRS-related symptoms, parenteral nutrition or supportive care required, signs of moderate/severe organ dysfunction), Grade 3 (severe) = hospitalization needed for management of at least one of the following (hypotension, hypoxia, organ dysfunction, coagulopathy), Grade 4 (life-threatening) = at least one of the following present (hypotension requiring high-dose vasopressors, hypoxia requiring mechanical ventilation).

Measure: Score on Cytokine Release Syndrome (CRS) Grading Scale

Time: Day 1

Description: Grade 1 (mild) = able to be managed with nonparenteral supportive care, Grade 2 (moderate) = at least one of the following present (hospitalization needed for management of CRS-related symptoms, parenteral nutrition or supportive care required, signs of moderate/severe organ dysfunction), Grade 3 (severe) = hospitalization needed for management of at least one of the following (hypotension, hypoxia, organ dysfunction, coagulopathy), Grade 4 (life-threatening) = at least one of the following present (hypotension requiring high-dose vasopressors, hypoxia requiring mechanical ventilation).

Measure: Score on Cytokine Release Syndrome (CRS) Grading Scale

Time: Day 6

Description: The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: Percentage of subjects reporting each severity score on 8 point ordinal scale Day 1 and EOT (End of Treatment - Day 6)

Time: 6 days

Description: (≥470 milliseconds in men; ≥480 milliseconds in women) on electrocardiogram at EOT (Day 6)

Measure: Percentage of subjects with qTC prolongation at EOT

Time: 6 Days

Description: Individual component of severe disease progression composite endpoint evaluated

Measure: Cumulative Incidence of mortality

Time: 30 days

Description: Individual component of severe disease progression composite endpoint evaluated

Measure: Cumulative Incidence of ICU admission

Time: 30 Days

Description: Individual component of severe disease progression composite endpoint evaluated

Measure: Cumulative Incidence of Invasive mechanical ventilation

Time: 30 Days

Description: Individual component of severe disease progression composite endpoint evaluated

Measure: Cumulative Incidence of ECMO

Time: 30 Days

Description: Individual component of severe disease progression composite endpoint evaluated

Measure: Cumulative Incidence of hypotension requiring vasopressor support

Time: 30 Days

Description: Laboratory endpoint, measured by RT-PCR

Measure: SARS-CoV-2 viral eradication from nasopharyngeal specimens at EOT

Time: 6 days

Description: Biochemistry lab-work will be completed to obtain ALT levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in Alanine Aminotransferase (ALT) levels

Time: Baseline, 6 days

Description: Biochemistry lab-work will be completed to obtain AST levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in Aspartate Aminotransferase (AST) levels

Time: Baseline, 6 days

Description: Biochemistry lab-work will be completed to obtain Creatinine levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in Creatinine levels

Time: Baseline, 6 days

Description: Biochemistry lab-work will be completed to obtain Glucose levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in Glucose levels

Time: Baseline, 6 days

Description: Hematology lab-work will be completed to obtain WBC count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in White Blood Cell (WBC) count

Time: Baseline, 6 days

Description: Hematology lab-work will be completed to obtain hemoglobin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in Hemoglobin levels

Time: Baseline, 6 days

Description: Hematology lab-work will be completed to obtain platelet count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in Platelet count

Time: Baseline, 6 days

Description: Biochemistry lab-work will be completed to obtain bilirubin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in total bilirubin levels

Time: Baseline, 6 days

Description: Biochemistry lab-work will be completed to obtain LDH levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in Lactate Dehydrogenase (LDH) levels

Time: Baseline, 6 days

Description: Biochemistry lab-work will be completed to obtain CRP levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in C-Reactive Protein (CRP) levels

Time: Baseline, 6 days

Description: Biochemistry lab-work will be completed to obtain IL-6 levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Measure: Change in Interleukin 6 (IL-6) levels

Time: Baseline, 6 days

Other Outcomes

Description: A titer is the concentration of an antibody. ELISA (enzyme-linked immunosorbent assay) is a plate-based assay technique designed for detecting and quantifying antibodies. Titers will be measured by ELISA.

Measure: Titers of serum anti-SARS-CoV-2 antibodies

Time: 8 weeks

Description: Real-time polymerase chain reaction (real-time PCR), also known as quantitative polymerase chain reaction (qPCR) (a laboratory technique of molecular biology) will be used to measure antigen-specific T cell count.

Measure: Antigen-specific T cell count

Time: 8 weeks


No related HPO nodes (Using clinical trials)