COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44408

D Mallikarjuna Rao

mallikarjunard@drreddys.com

2020-06-12

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab <br/ >Note: A re-treated/ relapsed patient may be enrolled if he/she meets all of the following criteria: <br/ >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 <br/ >AND <br/ >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 <br/ >AND <br/ >c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? COVID-19 disease severity <br/ >3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate â?¥24 breaths/minute, SpO2 <94% (90%-94%) on room air) <br/ >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). <br/ >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 <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment <br/ >5. Able and willing to provide informed consent <br/ >6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment

1. Patients with hypersensitivity or a contra-indication to hydroxychloroquine or nitazoxanide <br/ >2. Patients with history of or one or more known comorbidities at baseline: <br/ >a. Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure <br/ >b. Uncontrolled Diabetes Mellitus <br/ >Note: Investigators may use clinical discretion to enrol well controlled diabetic patients who are either currently receiving or not currently receiving anti-diabetic medications. <br/ >c. COPD, Asthma or Interstitial Lung Disease <br/ >d. Malignancy <br/ >e. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >f. G6PD deficiency <br/ >g. Psoriasis or porphyria <br/ >h. Kidney Disease (Serum creatinine > 1.5 times upper limit) <br/ >i. Liver disease (e.g. Child Pugh score â?¥ B or AST (Aspartate Transaminase) >3.5 times upper limit) <br/ >j. Cardiac conduction delay (QTc > 500 msec) <br/ >k. Retinopathy or macular degeneration <br/ >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). <br/ >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 <br/ >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. <br/ >6. Patients clinically assigned as having â??severeâ?? COVID-19 disease (Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock), critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of Randomization <br/ >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). <br/ >7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients <br/ >8. Inability to take oral medication. <br/ >9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >10. Current smoker or has quit smoking within last 3 months <br/ >11. Body Weight < 45 kg <br/ >12. Female patients who are pregnant or lactating <br/ >13. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg Methotrexate, Cyclosporine etc.) <br/ >14. Patients who are contemplating sur

2

Dr Reddys Laboratories Limited

18

65

India

Moderate disease at enrollment

3: Moderate disease at enrollment

158

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

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 2

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1567, "treatment_name": "Hydroxychloroquine+nitazoxanide", "treatment_type": "Antimalarials+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}]