Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Hydroxychloroquine: 600 mg QD (on Days 1 and 2) followed by 200 mg BID (on Days 3 to 14)
Intervention2: Nitazoxanide and Hydroxychloroquine: Nitazoxanide: 1000 mg QD (on Days 1 and 2) f
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab Note: A re-treated/ relapsed patient may be enrolled if he/she meets all of the following criteria: a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-2 after previous treatment AND b. Clinical symptoms associated with COVID-19 (fever, cough, fatigue, shortness of breath, expectoration, myalgia, rhinorrhea, sore throat, diarrhea, anosmia, ageusia) have either re-appeared after previous treatment OR continued to be present without improvement OR are aggravated AND c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? COVID-19 disease severity 3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate >=24 breaths/minute, SpO2 Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). 4. Females should have a negative serum pregnancy test at baseline; female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of 5. Able and willing to provide informed consent 6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator 7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity or a contra-indication to hydroxychloroquine or nitazoxanide 2. Patients with history of or one or more known comorbidities at baseline: a. Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure b. Uncontrolled Diabetes Mellitus Note: Investigators may use clinical discretion to enrol well controlled diabetic patients who are either currently receiving or not currently receiving anti-diabetic medications. c. COPD, Asthma or Interstitial Lung Disease d. Malignancy e. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) f. G6PD deficiency g. Psoriasis or porphyria h. Kidney Disease (Serum creatinine > 1.5 times upper limit) i. Liver disease (e.g. Child Pugh score >= B or AST (Aspartate Transaminase) >3.5 times upper limit) j. Cardiac conduction delay (QTc > 500 msec) k. Retinopathy or macular degeneration 3. In case of patients with symptoms associated with COVID-19 at screening assessment (ie, one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 10 days before screening (not applicable for re-treated/relapsed patients). 4. Receiving or has received antiviral therapy (including oseltamivir, zanamivir, favipiravir, umifenovir, ribavirin, anti- retroviral therapy with lopinavir and ritonavir (LPR/r)), nitazoxanide or ivermectin within 28 days or chloroquine/hydroxychloroquine in the six months prior to baseline visit 5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) in the 90 days prior to baseline visit. 6. Patients clinically assigned as having â??severeâ?? COVID-19 disease (Severe Pneumonia (with respiratory rate >=30/minute and/or SpO2 Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). 7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients 8. Inability to take oral medication. 9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption 10. Current smoker or has quit smoking within last 3 months 11. Body Weight 12. Female patients who are pregnant or lactating 13. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg Methotrexate, Cyclosporine etc.) 14. Patients who are contemplating sur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean viral load (determined by rRT-PCR on a nasopharyngeal/ oropharyngeal swab)Timepoint: Day 14 or at discharge from hospital, whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean viral load (determined by rRT-PCR on nasopharyngeal/ oropharyngeal swab)Timepoint: Days 3, 7 and 10;Changes of parameters at each assessment during the study/follow-up period, compared to baseline for: â?ª Vital signs: body temperature, heart rate, respiratory rate, systolic/diastolic blood pressure and oxygen saturation. â?ª Clinical Laboratory assessments: hematology, serum chemistry, urinalysis. â?ª 12-lead ECG: Changes in heart rate, PR, QRS, QT and QTcB intervalsTimepoint: Day 1 to Day 14;Mean change from baseline in National Early Warning Score 2 (NEWS-2) scoreTimepoint: Days 3, 7, 10 and 14;Mean change from baseline in patientâ??s clinical status on a 10-point ordinal scale (SOLIDARITY trial).Timepoint: Days 3, 7, 10 and 14;Mean/ median time (no. of days) the patient is: a. Managed in intensive care unit b. On Oxygen supplementation c. On Invasive mechanical ventilationTimepoint: Day 1 to Day 14;Mean/median time (no. of days) from start of treatment to discharge from hospitalTimepoint: Day 1 until discharge from hospital;Mean/median time (no. of days) to a. Management in intensive care unit b. Oxygen supplementation c. Invasive mechanical ventilationTimepoint: Day 1 to Day 14;Median time (no. of days) to negative conversion (of detectable SARS-CoV-2 viral RNA) on nasopharyngeal swabTimepoint: From Day 1 of treatment to negative conversion;Number (and percentage) of patients reporting treatment emergent adverse events (TEAEs)Timepoint: Day 1 to Day 14;Percentage of patients discharged from â??isolation wardâ?? of COVID-management hospital facilityTimepoint: Day 1 to Day 14;Percentage of patients dying due to COVID-19 complicationTimepoint: Day 1 to Day 14;Percentage of patients requiring of treatment: a. Management in intensive care unit (ICU) b. Oxygen supplementation c. Invasive mechanical ventilationTimepoint: Day 1 to Day 14;Percentage of patients showing negative conversion (of detectable SARS-CoV-2 viral RNA) on n | — |
Countries
India
Contacts
Public ContactD Mallikarjuna Rao
Dr Reddys Laboratories Limited
Outcome results
None listed