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Chloroquine or HydroxychloroquineWiki

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


Correlated Drug Terms (13)


Name (Synonyms) Correlation
drug2922 non-RAS blocking antihypertensives Wiki 0.58
drug518 Candesartan Wiki 0.58
drug338 Best standard of care Wiki 0.58
drug1870 Pleth variability index Wiki 0.58
drug2516 Thromboprophylaxis Wiki 0.58
drug2023 Ramipril 2.5 MG Oral Capsule Wiki 0.58
drug2952 placebo for clazakizumab Wiki 0.58
drug2105 Rivaroxaban Wiki 0.33
drug1368 Lopinavir/Ritonavir Wiki 0.33
drug1852 Placebo oral capsule Wiki 0.33
drug1481 Methotrexate Wiki 0.29
drug576 Clazakizumab Wiki 0.26
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.03

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 3 clinical trials

Clinical Trials


1 Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)

The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other staff working in a facility where there are cases of either proven, or suspected, COVID-19, who can be followed reliably for 5 months. 40,000 participants will be recruited and we predict an average of 400-800 participants per site in 50-100 sites. The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months. If the participant is diagnosed with COVID-19, they will take continue to take the study medication until: - 90 days after enrolment (i.e., completion of kit) - hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or - advised to stop by their healthcare professional for other reasons Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period.

NCT04303507 COVID19 Coronavirus Acute Respiratory Illnesses Drug: Chloroquine or Hydroxychloroquine Drug: Placebo
MeSH:Coronavirus Infections

Primary Outcomes

Description: Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups

Measure: Number of symptomatic COVID-19 infections

Time: Approximately 90 days

Secondary Outcomes

Description: Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.

Measure: Symptoms severity of COVID-19

Time: Approximately 90 days

Description: Number of asymptomatic cases of COVID-19 will be determined by comparing serology in all participants at time of enrolment and at the end of follow up.

Measure: Number of asymptomatic cases of COVID-19

Time: Approximately 90 days

Description: Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

Measure: Number of symptomatic acute respiratory illnesses

Time: Approximately 90 days

Description: Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

Measure: Severity of symptomatic acute respiratory illnesses

Time: Approximately 90 days

Other Outcomes

Description: Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, Acute Respiratory Infection and disease severity.

Measure: Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.

Time: Approximately 90 days

Description: Number of days lost to work in relation to the treatment arm

Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on number of days lost to work during the pandemic.

Time: Approximately 90 days

Description: The trial will collect data on monetary costs associated with the use of healthcare resources and determine the effects between treatment groups.

Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on healthcare costs

Time: Approximately 90 days

Description: The trial will collect data on health-related quality of life using the quality of life questionnaire (EQ-5D-3L) to determine the effects between treatment groups.

Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on quality of life measures using the quality of life questionnaire (EQ-5D-3L)

Time: Approximately 90 days

2 A Multicenter, Randomized, Active Controlled, Open Label, Platform Trial on the Efficacy and Safety of Experimental Therapeutics for Patients With COVID-19 (Caused by Infection With Severe Acute Respiratory Syndrome Coronavirus-2)

The Austrian Coronavirus Adaptive Clinical Trial (ACOVACT) is a randomized, controlled, multicenter, open-label basket trial that aims to compare various antiviral treatments for COVID-19. Moreover three substudies have been integrated. Currently, patients will be randomized to receive (hydroxy-)chloroquine, lopinavir/ritonavir or standard of care. Moreover, these patients are eligible for substudy A (randomized to rivaroxaban 5mg 1-0-1 vs. standard of care), substudy B (renin-angiotensin (RAS) blockade vs. no RAS blockade for patients with blood pressure >120/80mmHg), and substudy C (clazakizumab vs standard of care, for patients with respiratory deterioration and high inflammatory biomarkers). Endpoints were chosen based on the master protocol published by the World Health Organisation and include a 7-point scale of clinical performance, mortality, oxygen requirement (both dose and type), duration of hospitalization, viral load and safety.

NCT04351724 COVID-19 Drug: Chloroquine or Hydroxychloroquine Drug: Lopinavir/Ritonavir Other: Best standard of care Drug: Rivaroxaban Drug: Thromboprophylaxis Drug: Candesartan Drug: non-RAS blocking antihypertensives Drug: Clazakizumab Drug: placebo for clazakizumab
MeSH:Coronavirus Infections

Primary Outcomes

Description: The primary endpoint is time to clinical improvement which is defined as time from randomization to an (sustained) improvement of at least one category on two consecutive days compared to the status at randomization measured on a seven-category ordinal scale (proposed by WHO). The 7-categories of the World Health Organization proposed scale, as follows: 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. During hospitalization this score will be determined daily (till day 29). If a patient is released from the hospital before day 29, the score will be determined at day 11 and 29 after randomization (depending when the patient was released or by telephone call).

Measure: sustained improvement (>48h) of one point on the WHO Scale

Time: Inclusion to day 29, daily evaluation

Secondary Outcomes

Description: The scale described in the primary endpoint is used

Measure: Time to improvement on WHO Scale

Time: Inclusion to day 29, daily evaluation

Description: The scale described in the primary endpoint is used

Measure: Mean change in the ranking on an ordinal scale from baseline

Time: Inclusion to day 29, daily evaluation

Description: the National Early Warning Score includes respiratory rate, oxygen saturation, use of supplemental oxygen, temperature, systolic blood pressure, heart rate and levels of consciousness (AVPU Scale)

Measure: time to discharge or a National Early Warning Score (NEWS) ≤2 (maintained for 24h), whichever occurs first

Time: Inclusion to day 29, daily evaluation

Description: The scale described in the primary endpoint is used

Measure: change from baseline in National Early Warning Score (NEWS)

Time: Inclusion to day 29, daily evaluation

Measure: Oxygenation free days

Time: Inclusion to day 29, daily evaluation

Description: new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation

Measure: Incidence of new oxygen use during the trial

Time: Inclusion to day 29, daily evaluation

Measure: duration of oxygen use during the trial

Time: Inclusion to day 29, daily evaluation

Description: number of days with requirement of mechanical ventilation

Measure: Ventilator free days until day 29

Time: Inclusion to day 29, daily evaluation

Measure: Incidence of new mechanical ventilation use during the trial

Time: Inclusion to day 29, daily evaluation

Measure: duration of mechanical ventilation use during the trial

Time: Inclusion to day 29, daily evaluation

Description: obtained by polymerase chain reaction in nasal/oropharyngeal swabs, performed at baseline and then three times a week, if possible

Measure: Viral load/viral clearance

Time: Inclusion to day 29, daily evaluation

Measure: Duration of Hospitalization

Time: Inclusion to day 29, daily evaluation

Measure: Mortality

Time: 15-day, 29-day mortality

Description: BMI (kg/m2), within all subjects the impact of obesity on overall mortality will be investigated

Measure: Obesity - mortality

Time: BMI at admission, mortality until day 29

Description: BMI (kg/m2) , within all subjects the impact of obesity on the duration of hospitalization will be investigated

Measure: Obesity - duration of hospitalization

Time: BMI at admission, duration of hospitalization until day 29 or discharge

Description: BMI (kg/m2) , within all subjects the impact of obesity on ICU admission will be investigated

Measure: Obesity - ICU admission

Time: BMI at admission, ICU admission until day 29 or discharge

Description: BMI (kg/m2) new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation

Measure: Obesity - new oxygen use

Time: BMI at admission, new oxygen use until day 29 or discharge

Description: lopinavir and ritonavir both interact with numerous other drugs by inhibiting the cytochrome enzymes 3A4. Using commercially available drug-interaction programs, the number and severity grading of drug-drug-interactions will be documented (for instance uptodate interaction tool, medscape). This is an exploratory analysis of drug-drug interactions with the above mentioned substances. severity grading usually encompass "contraindicated", "serious", "monitor closely", "minor" interaction.

Measure: Drug-drug interactions with lopinavir/ritonavir

Time: Inclusion to day 29, daily evaluation

Description: for sub-study B only: RAS fingerprint measures metabolites involved in the renin-angiotensin-system. The influence of randomized treatment with candesartan (RAS blockade) will be analyzed

Measure: Renin Angiotensin System (RAS) fingerprint

Time: Inclusion to day 29, daily evaluation

3 Clinical Study Evaluating the Efficacy of Chloroquine or Hydroxychloroquine in COVID-19 Treatment

Chloroquine or hydroxychloroquine in COVID-19 treatment

NCT04353336 COVID-19 Coronavirus Infection Drug: Chloroquine or Hydroxychloroquine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: the number of patients with cure or death

Measure: Number of patients with cure or death

Time: 1 month


No related HPO nodes (Using clinical trials)