Covid 19 Research using Clinical Trials (Home Page)
Hydroxychloroquine (HCQ)Wiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (10)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1753 | Pacebo: Calcium citrate Wiki | 0.50 |
| drug1841 | Placebo for Hydroxychloroquine Wiki | 0.50 |
| drug2077 | ResCure™ Wiki | 0.50 |
| drug432 | CERC-002 Wiki | 0.50 |
| drug1840 | Placebo for Azithromycin Wiki | 0.50 |
| drug480 | COVID-19 positive via testing Wiki | 0.50 |
| drug263 | Azithromycin (Azithro) Wiki | 0.50 |
| drug575 | Clarithromycin Wiki | 0.50 |
| drug1853 | Placebo oral tablet Wiki | 0.09 |
| drug1822 | Placebo Wiki | 0.03 |
Correlated MeSH Terms (10)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003141 | Communicable Diseases NIH | 0.13 |
| D014947 | Wounds and Injuries NIH | 0.11 |
| D055370 | Lung Injury NIH | 0.11 |
| D007239 | Infection NIH | 0.08 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.08 |
| D018352 | Coronavirus Infections NIH | 0.06 |
| D014777 | Virus Diseases NIH | 0.06 |
| D011014 | Pneumonia NIH | 0.06 |
| D055371 | Acute Lung Injury NIH | 0.05 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.04 |
There are 4 clinical trials
Clinical Trials
1 Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric Randomized Comparative Study
Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study
NCT04349228 COVID19 Sars-CoV2 Hydroxychloroquine Prophylaxis Healthcare Worker Drug: Hydroxychloroquine (HCQ) Drug: Placebo oral tablet
Primary Outcomes
Description: Clinical Examination: Symptomatic COVID(+) infection rate (from randomization to the onset of signs suggestive of Covid19 infection or to the end of the study at 60 days) The rate of COVID19 infections is defined by the occurrence of the clinical signs below: Cough Dyspnea Fever Myalgia Arthralgia Rhinorrhea Anosmia Asthenia, fatigability Confirmation of the above symptoms and COVID(+) PCR infection during the 60days treatment period. Biological Examination : Measurement of viral load Ion, liver, kidney, haematological assessment Electrical Examination: ECG
Measure: Symptomatic COVID(+) infection rate Time: 60 days2 Off Label Study to Evaluate the Efficacy of HCQ for Pre-exposure Prophylaxis (PrEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Health Care Workers (HCWs) Who Are at High Risk of Occupational Exposure to SARS-CoV-2
Off label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 350 participants will be assigned to the group that takes HCQ or the group that opts to not take the study medication. Participants will be NYULH HCW at high risk for occupational exposure to SARS-CoV-2. Study timepoints will include screening/enrollment, 30 day, 60 day, and 90 day visits. Questionnaires, and DBS will be collected in all timepoints.
NCT04354870 COVID-19 Drug: Hydroxychloroquine (HCQ)
Primary Outcomes
Description: Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline.
Measure: Frequency of seroconversion to SARS-CoV-2 Time: baseline, 30 days, 60 days, 90 daysSecondary Outcomes
Description: To characterize whether high-risk HCW who seroconvert to SARS-CoV-2 have asymptomatic infection or report symptoms of COVID-19 in the 4 weeks preceding seroconversion (assessed by symptom questionnaire)
Measure: Incidence of COVID-19 symptoms in the 4 weeks preceding seroconversion Time: baseline, 30 days, 60 days, 90 daysDescription: Data collection from medical chart review
Measure: Hospital admission rate Time: baseline, 30 days, 60 days, 90 daysDescription: Data collection from medical chart review
Measure: ICU admission rate Time: baseline, 30 days, 60 days, 90 daysDescription: Data collection from medical chart review
Measure: Mortality rate Time: baseline, 30 days, 60 days, 90 daysDescription: To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population
Measure: Incidents of AEs or SAEs related to HCQ upon study termination time Time: 30 days, 60 days, 90 daysOther Outcomes
Description: Measured by Serology test, to characterize whether pre-existing of non-SARS-CoV-2 coronavirus antibodies are capable of causing antibody dependent enhancement of a pseudotyped SARS-CoV-2
Measure: Percentage of cells infected in the laboratory using a standardized dose of pseudotyped SARS-CoV-2 in the presence or absence of blood containing non-SARS-CoV-2 coronaviruses antibodies Time: baseline, 30 days, 60 days, 90 daysDescription: To determine whether hydroxychloroquine reduces time lost from work
Measure: Days away from work Time: baseline, 30 days, 60 days, 90 daysDescription: To assess the compliance of hydroxychloroquine PrEP
Measure: Frequency of missing HCQ dose Time: baseline, 30 days, 60 days, 90 days3 A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
The purpose of this study is to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.
NCT04358068 COVID-19 SARS-CoV 2 Drug: Hydroxychloroquine (HCQ) Drug: Azithromycin (Azithro) Drug: Placebo for Hydroxychloroquine Drug: Placebo for Azithromycin
Primary Outcomes
Description: Hospitalization is defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care is not considered a hospitalization.
Measure: Proportion of participants who died from any cause or were hospitalized Time: Measured during the 20-day period from and including the day of the first (confirmed) dose of study treatmentSecondary Outcomes
Measure: Proportion of participants who died from any cause Time: Measured during the 20-day period from and including the day of the first (confirmed) dose of study treatmentMeasure: Proportion of participants who died from any cause, or were hospitalized, or had an urgent visit to emergency room or clinic Time: Measured during the 20-day period from and including the day of the first (confirmed) dose of study treatment
Description: Hospitalization is defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care is not considered a hospitalization.
Measure: Proportion of participants who died from any cause or were hospitalized through the end of follow-up Time: Measured during the 20-day period from and including the day of the first (confirmed) dose of study treatmentMeasure: Proportion of participants who prematurely discontinue study treatment due to an adverse event Time: Measured through Day 7
Measure: Proportion of participants who had any cardiac adverse events Time: Measured from start of study treatment through Day 20
Description: Defined as the last day in the participant's daily diary card on which a temperature greater than 100.4°F was recorded or a potentially antipyretic drug, such as acetaminophen or ibuprofen, was taken.
Measure: Duration of fever Time: Measured through Day 20Description: Defined as the last day in the participant's daily diary card on which a moderate or worse symptom was recorded
Measure: Duration of symptoms associated with COVID-19 disease Time: Measured through Day 20Description: Defined as the sum of scores for the targeted symptoms (defined in the protocol) in the participant's daily diary record (each individual symptom is scored from 0 to 3).
Measure: Participant-specific area under the curve (AUC) of the symptom score associated with COVID-19 disease over time Time: Measured through Day 20Measure: Time to self-reported return to usual (pre-COVID) health. Time: Measured through Day 20
Measure: SARS-CoV-2 RNA detection status from self-collected nasal and site-collected NP swabs among subset Time: Measured at entry, Day 6, and Day 20
Measure: SARS-CoV-2 RNA level (continuous) from self-collected nasal and site-collected NP swabs among subset Time: Measured at entry, Day 6, and Day 20
4 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 daysMeasure: 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 daysSecondary Outcomes
Description: Events = mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support
Measure: Cumulative incidence of events Time: 30 daysDescription: 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 daysDescription: Defined as number of days with temperature >100.4 degrees Fahrenheit.
Measure: Days of fever Time: 14 daysDescription: 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 daysDescription: Defined as the number of days the subject was on a non-rebreather mask.
Measure: Days of non-rebreather mask oxygen supplementation Time: 14 daysDescription: 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 1Description: 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 6Description: 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 daysDescription: (≥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 DaysDescription: Individual component of severe disease progression composite endpoint evaluated
Measure: Cumulative Incidence of mortality Time: 30 daysDescription: Individual component of severe disease progression composite endpoint evaluated
Measure: Cumulative Incidence of ICU admission Time: 30 DaysDescription: Individual component of severe disease progression composite endpoint evaluated
Measure: Cumulative Incidence of Invasive mechanical ventilation Time: 30 DaysDescription: Individual component of severe disease progression composite endpoint evaluated
Measure: Cumulative Incidence of ECMO Time: 30 DaysDescription: Individual component of severe disease progression composite endpoint evaluated
Measure: Cumulative Incidence of hypotension requiring vasopressor support Time: 30 DaysDescription: Laboratory endpoint, measured by RT-PCR
Measure: SARS-CoV-2 viral eradication from nasopharyngeal specimens at EOT Time: 6 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysOther 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 weeksDescription: 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