COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44041

Dr Ramesh Kannan

srkguruvarshan@gmail.com

2020-05-30

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Willing and able to provide written informed consent prior to performing study procedures. <br/ >2. Males and females between the age of 18-50 years. <br/ >3. Mild to moderate COVID-19 associated disease as defined by the WHO. <br/ >4. Hospitalized patient. <br/ >5. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR. <br/ >6.Illness of any duration and febrile/afebrile. Febrile-defined as temperature � 36.6 °C armpit, � 37.2 °C oral, or � 37.8 °C rectal documented within 48 hours of consent. <br/ >

1. Participation in any other clinical trial of an experimental treatment for COVID-19 <br/ >2.Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study medication initiation <br/ >3.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) <br/ >4.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) <br/ >5.Pregnant women or women who are breastfeeding <br/ >6.Immunocompromised patients taking medication upon screening <br/ >7.Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment <br/ >

2

Apex Laboratories Pvt Ltd

18

55

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

100

a.Time taken for clinical recovery; which is defined as; <br/ >1. Normalization of pyrexia and body pain <br/ >2. Respiratory rate less than 24/minute <br/ >3.Spo2 rate greater than 94% <br/ >4. Relief from cough and maintenance of above for more than 72 hours. <br/ >b.Proportion of patients with swabs negative for COVID19 in RT PCR at day 5; 10 and 15 <br/ >c.Reduction of Viral Load. <br/ >Timepoint: At day 5; day 10 and day 15

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3/Phase 4

[{"arm_notes": "", "treatment_id": 294, "treatment_name": "Clevira", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]