COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46679

Dr Shashank Acharya

sruthi.nambiar@trialguna.com

2020-08-20

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Voluntarily participating in the clinical study, fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF) <br/ >1. Age 18-80 years (inclusive) at the time of signing ICF. <br/ >2. SARS-CoV-2 positive report â?? rtPCR or Rapid Antigen <br/ >3. Initial COVID-19 symptom onset within 4 days prior to Screening <br/ >4. For female subjects: evidence of post-menopause, or for pre-menopause subjectâ??s negative pre-treatment serum or urine pregnancy test <br/ >5. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment <br/ >6. SpO2 â?¥ 93% on room air <br/ >7. Not participating in any other interventional drug clinical studies before completion of the present study. <br/ >

Subjects meeting any of the following criteria must not be enrolled in the study: <br/ >1. Severe or critical COVID-19 illness: RR â?¥26, HR â?¥100, SpO2 <93% on room air or requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 â?¥95%, systolic blood pressure < 110 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300 <br/ >2. Inability to intake or tolerate oral medications. <br/ >3. Known asthma or COPD <br/ >4. Poorly controlled Diabetes <br/ >5. Lobar or segmental consolidation on chest imaging or on clinical signs. <br/ >6. Treatment with other drugs thought to possibly have activity against SARS-CoV-2 <br/ >7. ALT or AST > 5 x upper limit of normal (ULN) <br/ >8. Female subject is pregnant or breastfeeding <br/ >9. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely. <br/ >

2

Dyuthi Biosciences Private Limited

18

80

India

Moderate disease at enrollment

3: Moderate disease at enrollment

44

Time to Clinical recovery on a 7-point ordinal scale <br/ >The scale is as follows: 0) No clinical or virological evidence of infection; 1) No limitation of activities 2) Limitation of activities 3) Hospitalized; no oxygen therapy 4) Oxygen by mask or nasal prongs 5)Non-invasive ventilation or high-flow oxygen 6) Intubation and mechanical ventilation 7) Ventilation + additional organ support â?? pressors; RRT; ECMO 8) Death <br/ >Timepoint: At the end of the study (Time of clinical recovery)

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

Not reported

[{"arm_notes": "", "treatment_id": 16, "treatment_name": "Aceinavir", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]