Clinical trial NCT04920773: Community-based Post-exposure Prophylaxis for COVID-19
Official title: Community-based Post-exposure Prophylaxis for COVID-19: Results and Implications of Ayurveda Practice Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Post Exposure Prophylaxis
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Aarogyam UK
name: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
name: Samta Ayurveda Prakoshtha, India
name: Padmanabhama Ayurveda Hospital and Research Centre
First posted: 2021-06-10
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Specifically identified Ayurvedic preparations is recommended by ministry of AYUSH as post-exposure prophylaxis to efficaciously prevent a negative person who has come into contact with COVID-19-positive. Traditionally, recommended Ayurvedic preparations have been used as antioxidants, antimicrobial and anti-inflammatory properties. Particularly, Guduchi Ghanvati has been recognised with its ability to control viral attachment, viral replication and induce immune response in pre clinical settings, and found to be one among the most important drugs in Ayurveda to fight against COVID-19.

However, known gap in guideline implementation and its impact on preventing active infection in exposed cases is unclear. Study aimed to increase the use of recommended AYUSH guidelines by having registered AYUSH physicians provide these medications, when indicated, in community based participants after known exposure to the SARS-CoV-2 coronavirus.


Eligibility criteria: Inclusion Criteria:

* Men or women 18 to 60 years of age
* Household contact residing with the index case in the 14 days prior to index diagnosis within a residence without maintaining social distance
* Access to device and internet for telephonic appointments and follow up

Exclusion Criteria:

* Currently hospitalised
* Symptomatic with fever, cough, or shortness of breath
* Use of anti-malarial treatment or chemoprophylaxis
* Moderately or Severely ill for any co-morbid condition requiring medical assistance.
* Cognitive impairment

Primary outcomes:
measure: Number of participants with active COVID-19
timeFrame: 14-days following exposure
Secondary outcomes:
measure: Time to symptoms onset
timeFrame: 14-days
measure: Disease Severity
timeFrame: 14 days
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Research Institute
state: Rajasthan
city: Jaipur
country: India
facility: Padmnabham Ayurveda Hospital & Research Center
state: Rajasthan
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma
role: STUDY_CHAIR
affiliation: Niramaya clinic, India
name: Skanthesh Lakshmanan
role: STUDY_CHAIR
affiliation: NMP Medical Research Institute, India
name: Isha Goyal
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Abijith Venu
role: STUDY_CHAIR
affiliation: NMP Medical Research Institute
name: Sahil Singhal
role: STUDY_DIRECTOR
affiliation: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
name: Abhimanyu Kumar
role: STUDY_DIRECTOR
References: