An Open Label, Multicentre, Multi-Dose, Single Arm Treatment Clinical Trial in Human Adult, Patients With Mild COVID-19.

Not Applicable

Completed

• Registration Number: CTRI/2021/05/033846
• Lead Sponsor: Martin Sinclair BB Corp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-07-14
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1.Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.

2.Age 18-75 years (both inclusive) at the time of signing ICF.

3.Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization).

4.Patients with uncomplicated respiratory tract viral infection

5.For female patients: evidence of post-menopause or for Pre-menopause patients, negative pretreatment serum or urine pregnancy test.

6.Eligible patients 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.

7.Not participating in any other interventional drug clinical studies before completion of the present study

8.Controlled diabetic patients with HbA1C limit < 7.0

9.Hypertension Patients up till Hypertension Stage 2 shall be included in the study (Systolic blood pressure at least 140mm Hg and Diastolic blood pressure at least 90 mm Hg)

10.Time interval between symptoms onset and randomization to no more than 7 days.

11.Pyrexia (axillary > 98.6°F or frontal >99.5°F); or/and any of the following symptoms:

•Cough

•Sore throat

•Headache

•Nasal congestion

•Body aches and pains

•Fatigue

12.Patients with Loss of smell and Taste.

Exclusion Criteria

COVID - 19 patients with history or significant presence of the following will be excluded from participation/enrollment in the study trial:

1.Severe infection, defined as oxygen saturation (SPO2) <=93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) <=300 mmH or need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support.

2.Requires ICU care for management of ongoing clinical status.

3.Participation in this study will not be in the best interest of the patient, or any other circumstances that prevent the patient from participating in the study safely.

4.Inability to intake or tolerate oral medications like refractory nausea, vomiting, or gastrointestinal disorders, or having undergone extensive bowel resection which may affect adequate absorption of the drug.

5.Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis; CrCl is to be calculated by the following Cockcroft-Gault formula only when the serum creatinine is >1.5Ã?ULN.

6.patient has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary (Asthma, chronic obstructive lung disease), neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.

7.Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year).

8.Known severely reduced LV function (Ejection fraction <30%)

9. Severe liver disease: underlying liver cirrhosis or Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN.

10. Gout/history of gout or hyperuricemia (above the ULN).

11. Pregnant or lactating women.

12. Having participated in any other interventional drug clinical study within 30 days prior to first dose of study drug.

13. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission.

14.Patients with diabetes having HbA1C limit > 7.0

15. Patients with Hypertensive crisis.

Study & Design

• Study Type: Observational
• Study Design: Not specified