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This is a prospective, randomized, double-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection.
Full description
A total of 40 participants are planned for enrollment. Those enrolled into this study will be randomized 1:1 to receive either hydroxychloroquine or placebo control.
Participants will receive their study intervention for 5 days, after which they will be considered off protocol- directed therapy and receive medical management of their disease according to institutional standards. Participants may be followed for up to 180 days from initiating protocol therapy for clinical outcome, after which they will discontinue study participation.
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Volunteers
Inclusion criteria
Ability to understand and the willingness to sign a written informed consent document.
Individuals aged ≥ 18 years of all races and ethnic groups.
Must have documented positive test result for SARS-CoV-2 (COVID19), or high clinical suspicion for SARS-CoV-2 based on presence of typical clinical findings (e.g., fever, respiratory symptoms, pulmonary abnormalities on chest X-ray or CT scan), lack of alternative diagnosis, and history of exposure to a known case of SARS-CoV- 2 infection within the past 14 days
Not receiving institutional therapy for treatment of SARS-CoV-2, including (but not limited to) remdesivir, chloroquine, hydroxychloroquine, or any other investigational agent(s).
Must meet at least one of the following clinical stratifications:
i. Age ≥ 60 years old ii. Underlying medical comorbidities, defined as:
Patient must be within 5 days of symptom onset, as determined by clinical team.
Participants with preexisting auditory damage are allowed.
Participants with a history of epilepsy are allowed.
Female participants of childbearing potential (FOCBP) must have a negative serum or urine pregnancy test (per institutional standards) prior to the start of study drug.
FOCBP must agree to use highly-effective method(s) of contraception (Appendix B) during the study and for 1 months after the last dose of study drug. FOCBP are those who have not been surgically sterilized or have not been free from menses for >1 year without an alternative medical cause.
Male participants must agree to use an adequate method of contraception (Appendix B) starting with the first dose of study therapy through at least 1 months after the last dose of study drug.
Participant must agree to not breastfeed during the study or for 30 days after the last dose of study treatment.
Exclusion criteria
The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
Psychiatric illness/social situations, or any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results, or substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or participants with congenital long QT syndrome
Patients with Myesthenia Gravis or other neuromuscular disorders
Patients with history of psoriasis.
a. May be waived at the discretion of the PI
Patients with history of porphyria
a. May be waived at the discretion of the PI
Concomitant use of other antiviral agents for the study's duration, but may be waived at discretion of the Principal Investigator
Hypersensitivity to the study agent, or any of its excipients.
Females who are pregnant or lactating.
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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