A Phase III Clinical Study to assess the Safety and Efficacy of Ayurvedic Tablets combined with the current available medicine and its impact on lab parameters in Subjects with Uncomplicated Moderate COVID-19 infection.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/09/027817
- Lead Sponsor
- Bioved Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Male, Female
2.18 to 65 years
3.Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature >= 38 â?? (100.4 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate >=24 breaths per minute or Saturation of Oxygen (SpO2) <94% on room air}); and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed.
4.Subjects with laboratory confirmed SARS-CoV-2 infection (COVID-19) as determined by the Reverse Transcription Polymerase Chain Reaction (RT-PCR) or other approved commercially available or public health assay prior to Visit 1.
5.Onset of symptoms at least 48 hours before Visit 1 (Screening; study drug administration visit). The onset of symptoms is defined as either:
1.Time of the first increase in body temperature to >= 38 â?? (100.4 °F); or
2.Time when the subject experiences at least one general or respiratory symptom.
6.Subjects who are able to understand and willing to sign the informed consent form (ICF).
7.Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures.
8.All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation.
1.Subjects with severe COVID-19 infection requiring intensive inpatient treatment.
2.Subjects requiring mechanical ventilation or ECMO at the time of randomization on Day 1.
3.3.Subjects with severe symptoms such as respiratory rate > 30 breaths per minute or saturation of oxygen (SpO2) < 90% on room air.
4.Subjects with other concurrent infections requiring systemic antimicrobial and/or antiviral therapy prior to screening.
5.Administration of immunomodulators, interferon inducers, homeopathic, hormonal other than hormone replacement therapy, antiviral and antibacterial drugs during the previous 4 weeks before the first dose. Use of corticosteroids as part of the current standard of care is permitted.
6.Subjects who have any of the following documented conditions: uncontrolled hypertension systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg, diabetes, asthma any current or recent, not childhood if resolved, COPD any, cardiac, hepatic, renal including eGFRless than60 and hematopoietic disorders, bleeding tendency or hemorrhagic disease, neurological system disease, compromised immune system including patients receiving immunosuppressant therapy, or those with cancer within the past 5 years or human immunodeficiency virus HIV infection, endocrine disorders including thyroid disorders.
7.Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For example, nasal polyps or significant nasal septal deviation.
8.Clinically obese subjects with BMI less than or equal to 40.
9.Subjects with recent history within 6 months of alcoholism or substance abuse.
10.Participation in other clinical trial within 1 month, or during the study.
11.Pregnant or breast-feeding female subjects
12.Allergy or known allergy to components of study medication.
13.Previous history of difficulty swallowing capsules.
14.Any other associated disease or condition which, in the opinion of the investigator, might restrict or impede participation in the study or affect the study results.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate clinical efficacy of BV-4051 tablets in alleviation of fever and other symptoms including breathing difficulty, nasal congestion, sore throat, cough, headache, body ache, fatigue, chills or sweats, diarrhea, vomiting, taste and smell disorders in subjects with uncomplicated moderate SARS-CoV-2 infections (COVID-19).Timepoint: Day 7 and Day 14
- Secondary Outcome Measures
Name Time Method 1.Duration of viral shedding: defined as the time from treatment initiation to the time of first negative COVID-19 virus RNA by RT-PCR and/or to the time of first negative COVID-19 virus using other approved commercially available or public health assay. <br/ ><br>2.Reduction in Inerleukin-6, TNF-Alpha, Erythrocyte Sedimentation Rate, C-Reactive Protein and LDH from baseline to Day 7 or Early Discharge Visit Day and Day 14 post treatment initiation. <br/ ><br>Timepoint: Day 14 post treatment initiation.