Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection

Coronavirus Infection Clinical Trial

— WU352  

Official title:

Open-label, Randomized Controlled Trial of Hydroxychloroquine, Hydroxychloroquine Plus Azithromycin, Chloroquine Alone, Chloroquine Plus Azithromycin in the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04341727
• Other study ID #: 202003188
• Status: Terminated
• Phase: Phase 3
• Start date: April 4, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This Phase III trial will utilize four treatment strategies in non-critically ill hospitalized participants (not requiring mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin. Investigators are primarily interested in the time to recovery. In addition to study medications there will be daily symptom surveys for 14 days, then weekly thereafter for 4 weeks resulting in a total duration of follow up of 42 days. During hospitalization, daily symptom surveys will be completed in conjunction with the study coordinators. On discharge participants will have the option to complete electronic symptom surveys or complete symptom surveys via telephone with study coordinator. In the event that the participant opts for electronic symptom surveys on discharge participants will in addition receive a follow up call from a study coordination every 7 days during the initial 14 day period. In addition, failure to submit a symptom survey will prompt a study follow up call. Data from standard of care SOC will be collected from medical records.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalization for management of SARS CoV-2 infection

• Positive SARS CoV-2 test

• Age >=18 years

• Provision of informed consent

• Electrocardiogram (ECG) =48 hours prior to enrollment

• Complete blood count, glucose-6 phosphate-dehydrogenase (G6PD), comprehensive metabolic panel and magnesium =48 hours prior to enrollment from standard of care.

• If participating in sexual activity that could lead to pregnancy, individuals of reproductive potential who can become pregnant must agree to use contraception throughout the study. At least one of the following must be used throughout the study:

• Condom (male or female) with or without spermicide

• Diaphragm or cervical cap with spermicide

• Intrauterine device (IUD)

• Hormone-based contraceptive

Exclusion Criteria:

• Contraindication or allergy to chloroquine, hydroxychloroquine or azithromycin

• Current use hydroxychloroquine, chloroquine or azithromycin

• Concurrent use of another investigational agent

• Invasive mechanical ventilation

• Participants who have any severe and/or uncontrolled medical conditions such as:

• unstable angina pectoris,

• symptomatic congestive heart failure,

• myocardial infarction,

• cardiac arrhythmias or know prolonged QTc >470 males, >480 female on ECG

• pulmonary insufficiency,

• epilepsy (interaction with chloroquine),

• Prior retinal eye disease

• Concurrent malignancy requiring chemotherapy

• Known Chronic Kidney disease, eGFR<10 or dialysis

• G-6-PD deficiency, if unknown requires G6PD testing prior to enrollment

• Known Porphyria

• Known myasthenia gravis

• Currently pregnant or planning on getting pregnant while on study

• Breast feeding

• AST/ALT >five times the upper limit of normal ULN*

• Bilirubin >five times the ULN*

• Magnesium <1.4 mEq/L*

• Calcium <8.4mg/dL >10.6mg/dL*

• Potassium <3.3 >5.5 mEg/L*

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• Infections

Intervention

Drug:
• Hydroxychloroquine Sulfate
anti-rheumatic drug (DMARD)
• Azithromycin
Antibiotic
• Chloroquine Sulfate
Antimalarial

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Washington University School of Medicine Infectious Disease Clinical Research Unit	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours to Recovery	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 in each Arm/Group,respectively.	42 days
Secondary	Time to Fever Resolution	Time to resolution of fever defined as at least 48 hours since last temperature = 38.0°C without the use of fever-reducing medications in each Arm/Group,respectively.	42 days