Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients

Completed

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2020/07/026468

Lead Sponsor: AYUSHCSIR

Brief Summary: CoronavirusDisease-19 (COVID-19) pandemic has unleashed an unprecedented damage to life andlivelihood. Over four Million people have contracted the disease globally andalmost 2.7 lakh have died by the end of April2020. There is no specific therapyand the vaccine is likely to be readyby early 2021 if not earlier. Allthe global strategies are focussed on stringent measures to contain the virus and mitigate thesuffering of the people. India is under lockdown since early March 2020and the situation though grim is fairlystable. There is an upward trend in number of cases but the health care system is suitably meeting the challenge. Clinical research is a vital part of such epidemics. There is a dire need to find newer more effective drugs or at least improvethe current standard of care.

India has arich tradition of Ayurveda since ancient times and several â€—Rasayanaâ€˜ drugs arewell known to enhance the immunitystatus. Though COVID 19 is an acuteinfectious disease with a predominant affliction for lungs and airways, theclinical experience so far has showna rapidly progressive inflammation triggered by several exuberant immunologicalevents. Therefore, there may be apotent role of immunity enhancing and or immunomodulators drugs in the medical management of COVID 19. It is against this perspective that theMinistry of AYUSH and Council ofScientific & Industrial Research (CSIR) have initiated an ambitious andcomprehensive research program to discoverAyurveda formulations with proven value in thechemoprophylaxis and treatment of COVID 19.

This is a prospective, randomized, open label, blinded end point (PROBE), parallel efficacy, multicentric, two arm study to compare the efficacy of a combination of Standard of CareSOC) plus one of the selected individual Ayurveda herbal drug (Samshamani Vati Plus or AYUSH 64 or Yashtimadhu) to SOC (active control). The Ayurveda drug is being considered as an adjunctive or an add-on therapy and each of the three drugs will be evaluated in separate two arm trial with a common study design. The drug trials are â€— â€˜exploratoryâ€™ in design. The Study Flow diagram summarizes the study design and schedule of events

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 140

Inclusion Criteria

i) Typical clinical presentation of acute onset febrile illness with cough and a RT_PCR based laboratory confirmation test for COVID-19.
The patients may have other symptoms such as fever (patients with episodes of fever up to 48 hrs.
and constant fever reading will be considered), myalgia, headache, diarrhoea and tastelessness suggestive of COVID-19.
Patients with mild to â€“moderate diseasePatients must agree not to share medication iii.
Patients willing to participate and sign an informed consent.

Exclusion Criteria

Patients suffering from severe COVID-19 Disease as judged by a physician ii.
Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study iii.
History of immunosuppression: solid organ or bone marrow transplant, use of immunosuppressive antimetabolic and biologic agents, intrinsic immunodeficiencies, HIV infection.
Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
Atleast one fever episode every 24 hours for > 72h vi.
Patients on parenteral nutrition vii.
Patients with known sensitivity or contraindication to any of the ingredients of study medication viii.
History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) ix.
Patients who are likely to worsen or planned ICU admission or ventilator support due to any reason x.
Pregnancy and lactation xi.
Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19 xii.
Participation in any other clinical trial of an experimental agent treatment for COVID-19 xiii.
Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind.
Physician decision that involvement in the study is not in the patientÂ´s best interest.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)]	From baseline up to 12 weeks
b) Proportion of patients showing clinical recovery	From baseline up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
1) Rate of patients with negative SARS-CoV-2 on nasal or throat swab in a 2 day continuous real time RT-PCR test	2) Timelines (days counted from onset of illness)- normal body temperature, absence or minimal cough (see â€—clinical recoveryâ€˜ for the definition), absence of dyspnoea, onset of clinical pneumonia, pneumonia

Trial Locations

Locations (5): AVBRH DMIMS
🇮🇳
Wardha, MAHARASHTRA, India
Banaras Hindu University
🇮🇳
Varanasi, UTTAR PRADESH, India
Meditrina Institute of Medical Sciences
🇮🇳
Nagpur, MAHARASHTRA, India
MGM Medical College and Hospital
🇮🇳
Aurangabad, MAHARASHTRA, India
Noble Hospital PVt. Ltd.
🇮🇳
Pune, MAHARASHTRA, India
AVBRH DMIMS
🇮🇳Wardha, MAHARASHTRA, India
Dr Sunil Kumar
Principal investigator
9850393787
sunilkumarmed@gmail.com