Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Purified aqueous extract of Cocculus hirsutus (AQCH) tablets: Two tablets of 300 mg Orally, TID (every 8�±1 hours) at least 30 minutes before meals preferably at the same time every d
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female patient aged more than or equal to 18 years of age 2. Patients with laboratory confirmed COVID-19 disease by SARS-CoV-2 positive RT-PCR test (within 48 hours prior to enrollment) 3. Patients who had initial onset of signs/symptoms attributable to COVID-19 disease for less than or equal to 5 days prior to the day of randomization 4. Patients who had fever more than or equal to 100.4�ºF (oral or axillary temperature) within last 5 days and have at least one of the following respiratory symptoms attributable to COVID-19 disease: cough, runny nose, and sore throat 5. Patients with SpO2 more than or equal to 95% and respiratory rate less than or equal to 20 breaths/minute 6. Patients who have at least one of the following high-risk factors: Age more than 60 years, BMI more than 27 kg/m2, Hypertension (Patients with SBP 140 to 200 mm Hg and/or DBP 90 to 110 mm Hg OR on anti-hypertensive medication), T2DM (Patients with confirmed diagnosis of T2DM with FBG more than or equal to 126 mg/dL or PPBG more than or equal to 200 mg/dL OR on anti-diabetic medication), Bronchial Asthma (Patients with documented diagnosis of Bronchial Asthma since at least one year prior to screening), COPD (Patients with documented diagnosis of COPD since at least one year prior to screening) 7. Patient who provides written/electronic informed consent and agrees to comply with study procedures 8. Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence) [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age.].
Exclusion criteria
Exclusion criteria: 1. Patients with moderate to severe COVID-19 disease at randomization 2. Patients with known active hepatitis, tuberculosis, and definite bacterial or fungal infections 3. Patients with inability to take or tolerate oral medications 4. Patients requiring ICU monitoring and the treatment 5. Patients who have received one or two doses of vaccine for COVID-19 disease 6. Patients with AST or ALT more than 3 times ULN 7. Patients on dialysis or has reduced eGFR less than 30 mL/min/1.73 m2 (by the MDRD equation) 8. Patients with prolonged QTc-interval at baseline ECG (more than 450 ms in males or more than 470 ms in females) 9. Patients with history of hypersensitivity towards any drug of SOC 10. Patient has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the patientââ?¬•s safety or any other circumstances that prevent the patient from participating in the study 11. Patients with conditions that could limit gastrointestinal absorption of drug 12. Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus. 13. Patients who have received other antiviral drugs such as favipiravir or remdesivir, monoclonal antibodies or corticosteroids within 5 days prior to randomization 14. Patients who had participated in another investigational study within 3 months prior to enrolment in this study. 15. Investigators, study personnel, Sponsorââ?¬•s representatives and their first-degree relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who progress in COVID-19 disease severity from ââ?¬Ë?Mild diseaseââ?¬â?¢ to ââ?¬Ë?Moderate or Severe diseaseââ?¬â?¢Timepoint: Time frame: up to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with clinical cure at Days 5, 7, 9, 11 and 14Timepoint: at Days 5, 7, 9, 11 and 14;Proportion of patients with clinical improvement at Days 5, 7, 9, 11 and 14Timepoint: at Days 5, 7, 9, 11 and 14;Proportion of patients with negative SARS-CoV-2 RT-PCR in upper or lower respiratory tract specimenTimepoint: Time Frame: Days 3, 5, 7, 9, 11 and 14;Safety evaluation, as measured by TEAEs and SAEsTimepoint: Time Frame: up to 14 days from Baseline;Time to clinical cure based on clinician assessmentTimepoint: Time Frame: up to 14 days from Baseline;Time to clinical improvementTimepoint: Time Frame: up to 14 days from Baseline;Time to negative SARS-CoV-2 RT-PCR in Nasopharyngeal and/or oropharyngeal swabTimepoint: Time frame: up to 14 days from Baseline | — |
Countries
India
Contacts
Public ContactNilesh R Kadam
Sun Pharma Laboratories Limited
Outcome results
None listed