An aDaptive, multicEnter, rAndomized, Open-Label, Controlled Trial to Assess Effectiveness and Safety of Quinine Sulfate for COVID-19 in Hospitalized Adults

Pharm-202005.12

This is a multicenter, randomized, open-label, controlled trial to evaluate the effectiveness and safety of Quinine Sulfate as an add-on therapy in hospitalized adults with COVID-19. The study is a multi-center trial that will be conducted in up to approximately 2 sites nationally. New sites may be added as needed after appropriate assessment. Interim monitoring will be conducted to evaluate the arms and for safety and effectiveness. Any changes would be accompanied by an updated sample size. Subjects will be assessed while hospitalized. All subjects will undergo a series of laboratory tests (CBC, SGOT, SGPT, Ureum, Creatinine, EKG, and PCR), clinical examination (clinical assessment, vital signs, accompanying drugs, and other medical conditions) and safety assessment (serious adverse events/ SAE) Randomization will be performed 1:1 for each arm. Arm 1 = Standard of Care (SoC) alone, arm 2 = SoC + Quinine Sulfate

2021-04-26

2022-06-30

2023-05-31

Recruiting

100

Inclusion Criteria: * Male and female patients aged ≥ 18 years to 50 years old who are hospitalized with Covid-19 based on clinical symptoms determined by physician and confirmed by Rapid Test or PCR test with mild to moderate symptoms * Female subjects of child-bearing age agree to take effective contraceptive measures during the study until seven days of the last oral medication * Willing to receive a random assignment to any designated treatment group and not participating in another study at the same time * Not participating in other research at the same time. * Subjects agreed to participate in the study and signed an information sheet and informed consent. Exclusion Criteria: * Received quinine sulfate, hydroxychloroquine, chloroquine, lumefantrine, or mefloquine within 30 days prior to this research; * Having receive any treatment for COVID-19 prior to this research; * Any contraindication to quinine sulfate * Inability to swallow pills or any other reason that compliance with the medical regimen is not likely; * Pregnant and breastfeeding; * Severe underlying disease where treatment and follow up is not likely to be beneficial to the patient based on physician judgement (e.g. retinopathy, cardiovascular disease (QTc \> 500 mdet (narrow QRS); QTc ≥ 550 mdet (wide QRS)), heart arrythmia, uncontrolled diabetes mellitus, hypertension, chronic pulmonary disease, asthma, chronic kidney disease (Creatinine \> 2x normal value), liver disease (SGOT/SGPT \> 2x normal value), chronic neurological disease, or etc.). This includes people requiring care in designated supported living facilities and severe dementia; * Platelet count less than 150,000 and more than 450,000 cells/μL; * Possibility of being transferred to a non-study-hospital within 72 hours.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomised to be in Arm 1 or Arm 2 using pre-defined randomisation list; 1:1 for each arm.\n\nArm 1 receives Standard of Care Arm 2 receives Standard of Care+Quinine Sulfate', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-04-11