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Hydroxychloroquine SulfateWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (22)


Name (Synonyms) Correlation
drug87 Azithromycin Tablets Wiki 0.45
drug378 Hydroxychloroquine Sulfate + Azythromycin Wiki 0.32
drug166 CYNK-001 Wiki 0.32
drug261 Dexmedetomidine Injectable Product Wiki 0.32
drug684 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki 0.32
drug972 lopinavir/ritonavir Wiki 0.32
drug876 Umbilical Cord Mesenchymal Stem Cells Wiki 0.32
drug449 Ivermectine Wiki 0.32
drug84 Azithromycin 500 mg Wiki 0.32
drug377 Hydroxychloroquine Sulfate + Azithromycin Wiki 0.32
drug41 Alteplase 50 MG [Activase] Wiki 0.32
drug40 Alteplase 100 MG [Activase] Wiki 0.32
drug946 convalescent plasma Wiki 0.22
drug192 Chloroquine Sulfate Wiki 0.22
drug60 Ascorbic Acid Wiki 0.18
drug632 Placebos Wiki 0.17
drug668 Questionnaire Wiki 0.16
drug480 Losartan Wiki 0.12
drug771 Standard of Care Wiki 0.11
drug82 Azithromycin Wiki 0.07
drug360 Hydroxychloroquine Wiki 0.04
drug616 Placebo Wiki 0.03

Correlated MeSH Terms (21)


Name (Synonyms) Correlation
D007154 Immune System Diseases NIH 0.32
D000071257 Emergence Delirium NIH 0.32
D030341 Nidovirales Infections NIH 0.22
D012327 RNA Virus Infections NIH 0.22
D003693 Delirium NIH 0.22
D003333 Coronaviridae Infections NIH 0.18
D008171 Lung Diseases, NIH 0.16
D007239 Infection NIH 0.16
D045169 Severe Acute Respiratory Syndrome NIH 0.16
D055371 Acute Lung Injury NIH 0.15
D003141 Communicable Diseases NIH 0.15
D013577 Syndrome NIH 0.15
D012127 Respiratory Distress Syndrome, Newborn NIH 0.14
D007249 Inflammation NIH 0.14
D012128 Respiratory Distress Syndrome, Adult NIH 0.13
D018352 Coronavirus Infections NIH 0.12
D012140 Respiratory Tract Diseases NIH 0.12
D014777 Virus Diseases NIH 0.10
D012141 Respiratory Tract Infections NIH 0.08
D011024 Pneumonia, Viral NIH 0.05
D011014 Pneumonia NIH 0.03

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 10 clinical trials

Clinical Trials


1 Norwegian Coronavirus Disease 2019 Study: An Open Labeled Randomized Controlled Pragmatic Trial to Evaluate the Antiviral Effect of Chloroquine in Adult Patients With SARS-CoV-2 Infection

In the current proposal, the investigators aim to investigate the virological and clinical effects of chloroquine treatment in patients with established COVID-19 in need of hospital admission. Patients will be randomized in a 1:1 fashion to standard of care or standard of care with the addition of therapy with chloroquine.

NCT04316377 Corona Virus Infection Drug: Hydroxychloroquine Sulfate
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

Primary Outcomes

Description: Viral load assessed by real time polymerase chain reaction in nasopharyngeal samples

Measure: Rate of decline in SARS-CoV-2 viral load

Time: Baseline (at randomization) and at 96 hours

Secondary Outcomes

Description: National Early Warning Score score determines the degree of illness of a patient. Scores range from 0-20, with a higher score representing further removal from normal physiology and a higher risk of morbidity and mortality.

Measure: Change in National Early Warning Score score

Time: Baseline (at randomization) and at 96 hours

Description: Transfer from regular ward to intensive care unit during index admission

Measure: Admission to intensive care unit

Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)

Description: All-cause mortality during index admission

Measure: In-hospital mortality

Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)

Description: Total days admitted to the hospital (difference between admission date and discharge date of index admission)

Measure: Duration of hospital admission

Time: During index admission (between admission and discharge, approximately 21 days)

Description: All-cause mortality assessed at 30 and 90 days

Measure: Mortality at 30 and 90 days

Time: At follow-up 30 and 90 days

Description: Percentage of subjects reporting each severity rating on a 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: Clinical status

Time: 14 days after randomization

2 Comparison Of Therapeutics for Hospitalized Patients Infected With SARS-CoV-2 In a Pragmatic aDaptive randoMizED Clinical Trial During the COVID-19 Pandemic (COVID MED Trial)

Although a number of therapeutics are being utilized by clinicians to treat patients with COVID-19, none have been systematically evaluated in clinical trials. Lopinavir/ritonavir, an antiretroviral medication, showed equivocal but possibly positive efficacy and safety in a RCT conducted in China and published in NEJM in March of 2020. Hydroxychloroquine, an antimalarial and anti-inflammatory medication, has shown potent antiviral activity in vitro and elimination of viral shedding in a small pilot clinical trial. Losartan, an angiotensin II receptor blocker (ARB), has theoretical benefit as SARSCoV-2 appears to bind to lung tissue via Angiotensin-Converting Enzyme 2 (ACE-2) receptors which might be inhibited by ARBs. This pragmatic adaptive trial compares outcome in COVID-19 patients treated with lopinavir/ritonavir, hydroxychloroquine, losartan, and placebo.

NCT04328012 SARS-CoV-2 Infection Drug: lopinavir/ritonavir Drug: Hydroxychloroquine Sulfate Drug: Losartan Drug: Placebos

Primary Outcomes

Description: difference in NCOSS scores between the different treatment groups

Measure: National Institute of Allergy and Infectious Diseases COVID-19 Ordinal Severity Scale (NCOSS)

Time: 60 days

Secondary Outcomes

Description: difference in the total inpatient LOS between the four treatment groups

Measure: Hospital length of stay (LOS)

Time: 60 days

Description: difference in the total ICU level care LOS between the four treatment groups

Measure: Intensive care unit level LOS

Time: 60 days

Description: difference in length of use of mechanical ventilation between the four treatment groups

Measure: Mechanical ventilation

Time: 60 days

Description: difference in all cause mortality between the four treatment groups

Measure: survival

Time: 60 days

3 Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study

This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).

NCT04328961 COVID-19 Corona Virus Infection SARS (Severe Acute Respiratory Syndrome) SARS-CoV-2 Drug: Hydroxychloroquine Sulfate Drug: Ascorbic Acid
MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome Virus Diseases

Primary Outcomes

Description: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days

Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection

Time: Day 1 through Day 14 after enrolment

Description: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit

Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection

Time: Day 28 after enrolment

Secondary Outcomes

Description: Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults

Measure: Rate of participant-reported adverse events

Time: 28 days from start of Hydroxychloroquine therapy

Description: PCR-confirmed COVID-19 diagnosis

Measure: Incidence rates of COVID-19 through study completion

Time: 28 days from enrolment

4 Open, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus

This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.

NCT04329572 COVID-19 Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Tablets

Primary Outcomes

Description: Evaluation of change from baseline. Kaplan-meier method will be used.

Measure: Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability

Time: 28 days

Secondary Outcomes

Description: Evaluation of change in viral load

Measure: Viral load

Time: Day 6

Description: Time for normalization of body temperature, respiratory rate and cough relief

Measure: Change in Clinical Condition

Time: 28 days

Description: Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;

Measure: Evolution of Acute Respiratory Syndrome

Time: 28 days

Description: Time to be discharged from hospital

Measure: Hospital discharge

Time: 28 days

Description: Evaluation of change in acute respiratory syndrome

Measure: Rate of mortality within 28-days

Time: 28 days

5 Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19

This is a three-arm randomized trial comparing the efficacy of single agent hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of treatment in order to determine which regimen is more effective.

NCT04336332 SARS-CoV-2 COVID-19 Combination Product: Hydroxychloroquine Sulfate + Azithromycin Drug: Hydroxychloroquine Sulfate

Primary Outcomes

Description: Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.

Measure: Changes in patients viral load

Time: Baseline, day 3 and day 6

Description: A second concurrent comparison will evaluate change in viral load at day 6 between hydroxychloroquine sulfate alone and supportive care.

Measure: Second evaluation of changes in patients viral load

Time: Day 6

Secondary Outcomes

Description: Time to resolution of symptoms

Measure: Symptom questionnaire

Time: up to 6 months

Description: Change in the fever curve resulting in shorter time to afebrile for 48 hours

Measure: Fever assessment

Time: up to 10 days

Description: Body temperature will be measured in degrees Fahrenheit using an automated thermometer which will be provided to the patient 4 times per day.

Measure: Vital Signs - Body Temperature

Time: up to 10 days

Description: Time to discharge (If hospitalized)

Measure: Discharge

Time: up to 6 months

Description: Time to recovery (back to school, work, etc)

Measure: Recovery

Time: up to 6 months

Description: As measured by standard metrics

Measure: Assessment of agent toxicity

Time: up to 10 days

Description: Collection of Oropharynx swabs for viral load and microbiome analysis

Measure: Oropharynx swab sample collections

Time: up to 10 days

Description: Collection of blood for viral load and microbiome analysis

Measure: Blood Sample collections

Time: up to 10 days

Description: Decrease in virus shedding in nasopharyngeal secretions such as Ferritin, D-dimer, CRP, Troponin and LDH

Measure: Viral shedding assessment - nasopharyngeal secretions

Time: up to 10 days

Description: Decrease in virus shedding in serology such as Ferritin, D-dimer, CRP, Troponin and LDH

Measure: Viral shedding assessment - serology

Time: up to 10 days

Description: Measurement of cytokines in blood

Measure: Cytokines in blood

Time: up to 10 days

6 WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection

This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

NCT04341727 Coronavirus Infection Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Chloroquine Sulfate
MeSH:Infection Communicable Diseases Coro Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death

Measure: Hours to recovery

Time: 42 days

Secondary Outcomes

Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications

Measure: Time fever resolution

Time: 42 days

7 Randomized Controlled Trial of Hydroxychloroquine Versus Placebo for the Treatment of Adult Patients With Acute Coronavirus Disease 2019 - COVID-19

The current outbreak of COVID-19 caused by SARS-CoV-2 is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>9500) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 replication and anecdotal reports from COVID-19 patients in China and France suggest that chloroquine or hydroxychloroquine is a good candidate for treatment. In the French study a favourable effect was seen when hydroxychloroquine was used together with azithromycin in a small series of COVID-19 patients. However, so far all published evidence is based on non-controlled use of hydroxychloroquine. We propose to conduct a placebo-controlled trial in COVID-19 patients with mild to moderate disease in Germany to assess virological efficacy, tolerability and safety of hydroxychloroquine in the treatment of COVID-19. The objective of this trial is to identify an effect of hydroxychloroquine on viral clearance in vivo. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post-exposure prophylaxis of COVID-19.

NCT04342221 COVID-19, Hydroxychloroquine Sulfate Drug: Hydroxychloroquine Sulfate Drug: Placebo

Primary Outcomes

Description: Viral clearance defined as time to sustained SARS-CoV-2-specific RNA copy number ≤100, measured by real time reverse-transcription polymerase chain reaction RT-PCR in throat swabs.

Measure: Effect of HCQ on in vivo viral clearance

Time: 6 months

Other Outcomes

Measure: In-hospital mortality

Time: 60 days

Measure: All-cause mortality

Time: 60 days

Measure: Proportion requiring non-invasive or invasive ventilation

Time: 6 months

Measure: Proportion admitted to ICU

Time: 6 months

Measure: Duration of hospitalization

Time: 6 months

Measure: Reduction in viral RNA load in upper respiratory tract specimen as assessed by area under viral load curve

Time: 6 months

Measure: Reduction in viral RNA load in upper respiratory tract specimen defined as decline of RNA load by 2 log-levels or to below detection level

Time: 6 months

8 Adjuvant Use of Ivermectin To Hydroxychloroquine and Azithromycin in Patients With Covid19: A Novel Double Blind Placebo Controlled Pilot Study

Comparing the efficacy and safety of adjuvant use of Ivermectin in covid19 patients with pneumonia using Ivermectin with hydroxychloroquine compared to HCQ

NCT04343092 COVID 19 Drug: Ivermectine Drug: Hydroxychloroquine Sulfate Drug: Placebos Drug: Azithromycin 500 mg

Primary Outcomes

Description: Number of patients cured assessed by Nasopharyngeal swab, oropharyngeal swab, and blood aspiration for covid19 (PCR) in addtion to Chest xary

Measure: Number of cured patients

Time: 2 weeks

Secondary Outcomes

Description: Adverse events are assessed by Complete blood count (CBC), Liver function tests (ALT, AST),Renal function tests (blood urea, serum creatinine) and Fasting blood sugar test

Measure: Number of participants with treatment-related adverse events

Time: 2 weeks

9 Open Label, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Mild Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus

This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.

NCT04348474 Covid-19 Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Tablets

Primary Outcomes

Description: Ordinal scale (7 points ordinal scale that measures illness severity over time)

Measure: Change in Clinical Condition

Time: 28 days

Secondary Outcomes

Description: Number of patients that needed to be hospitalized

Measure: Hospitalization

Time: 28 days

Description: Time for normalization of body temperature

Measure: Change in Clinical Condition

Time: 28 days

Description: Time for normalization of of respiratory rate

Measure: Change in Clinical Condition

Time: 28 days

Description: Time for cough relief

Measure: Change in Clinical Condition

Time: 28 days

Description: Evaluation of change in acute respiratory syndrome

Measure: Rate of mortality within 28-days

Time: 28 days

Description: Subgroup analysis by comorbidities

Measure: Change in Clinical Condition related to comorbidity

Time: 28 days

10 Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)

The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.

NCT04361461 Coronavirus Infections SARS-CoV 2 SARS (Severe Acute Respiratory Syndrome) Pulmonary Disease Drug: Hydroxychloroquine Sulfate Drug: Hydroxychloroquine Sulfate + Azythromycin
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.

Measure: Individual response rate

Time: 14 days after randomization

Secondary Outcomes

Description: All-cause mortality rates at Day 28th after randomization

Measure: All-cause mortality

Time: 28 days after randomization

Description: Number of days that the patient was on mechanical ventilation which was under ventilation from basal line

Measure: Duration of mechanical ventilation

Time: baseline

Description: Proportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization.

Measure: Proportion of patients which needed mechanical ventilation during study

Time: hospitalization within 28 days

Description: The ordinal scale is an assessment of the clinical status at the first clinical evaluation in a clinical study. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (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: World Health Organization (WHO) Ordinal scale

Time: 28 days after inclusion and compared to baseline

Description: Length of hospital stay in days for hospitalization

Measure: Duration of hospitalization

Time: hospitalization within 28 days

Description: Rates of drug discontinuation in all causes under study

Measure: Rates of drug discontinuation

Time: hospitalization within 28 days

Other Outcomes

Description: Rates of serious adverse events

Measure: Rates of serious adverse events

Time: Day 14th


No related HPO nodes (Using clinical trials)