START (Siddha Treatment Accelerating Recovery from SARS-CoV-2 Test) trial of Siddha treatment for patients with novel coronavirus infectious disease (COVID-19)
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN13311119
- Lead Sponsor
- Eminentlabs GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 116
1. Aged between 18 and 75 years
2. Laboratory-confirmed COVID-19
3. Presence of any 2 symptoms of COVID-19: fever, cough, sore throat, myalgia, fatigue, headache or dyspnea
4. Not currently hospitalized or under immediate consideration for hospitalization. Hospitalization is defined as admission where patients require parenteral/Intravenous (IV) medications or IV fluids, oxygen or ventilatory support in hospital. Isolation or quarantine inside the hospital premises alone will not be considered as hospitalization.
5. Meets clinical features of the following grades of severity:
5.1. Suspected/confirmed cases in COVID Care Centres, clinically assigned as mild and very mild, presenting with fever and/or upper respiratory tract illness
5.2. Suspected/confirmed cases in Dedicated COVID Health Centres, clinically assigned as moderate, presenting with pneumonia with no signs of severe disease (Respiratory Rate 15 to 30 breaths/minute, SpO2 90%-94%)
6. Willing to practice contraception during the entire study treatment period and for 3 months after the last treatment of IMP is administered, using either double barrier contraception or sexual abstinence (when this is in line with the preferred and usual lifestyle of the participant)
7. Patients or their legal representatives have personally signed and dated signed the informed consent form (ICF) before completing any study-related procedure, which means before any assessment or evaluation that would not have formed a part of his normal medical care
8. Willing to adhere and comply with the protocol-related procedures
9. Willing to take Siddha drug regimen for COVID-19 infection
10. Willing to not participate in other clinical studies within 30 days after the last administration from the first administration of the study drug
1. Viral pneumonia with cause other than SARS-CoV-2
2. Severe or critical COVID-19 infection
3. Taken antibiotics/antivirals in the past 1 week
4. History of Asthma, COPD or any other chronic lung disease
5. Active malignancy
6. Received organ transplantation in the past 6 months or planning surgery
7. Unable to take food or drugs orally
8. Malabsorption or GI abnormalities which may affect drug absorption
9. Severe underlying diseases affecting survival, including but not limited to: blood diseases, dyscrasia, active bleeding, severe malnutrition, etc.
10. Subjects who are pregnant or lactating, have a pregnancy plan (including plans for sperm donation or egg donation), or who may fail to take effective contraceptive measures within the next 6 months
11. Allergic constitution, or known allergy to investigational products
12. Testing positive for HIV, Hepatitis B and Hepatitis C at screening
13. Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal.
14. Requiring Extracorporeal Life Support Program (ECLS), i.e. Extracorporeal Membrane Oxygenation (ECMO), Extracorporeal carbon dioxide removal (ECCO2R) or Registered Respiratory Therapist (RRT)
15. Life expectancy < 48 h
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients confirmed as negative for COVID-19 in 2 consecutive throat/nasal swabs (taken 24 hours apart) at 15 and 16 days
- Secondary Outcome Measures
Name Time Method