Community-based Post-exposure Prophylaxis for COVID-19

Study Overview
=================
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.

Official Title
-----------------
Community-based Post-exposure Prophylaxis for COVID-19: Results and Implications of Ayurveda Practice Guidelines

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: Guduchi Ghanvati
* Other: Standard guidelines


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ayurveda Care Group<br>Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask Samshamani vati or Giloy Ghanavati | Other: Guduchi Ghanvati<br>* 500 mg of Samshamani vati or Giloy Ghanavati (Aqueous extract of Tinospora cordifolia) twice daily<br>Other: Standard guidelines<br>* Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask<br>|
| Active Comparator: Usual Care Group<br>Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask | Other: Standard guidelines<br>* Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with active COVID-19 | PCR- proven COVID-19 | 14-days following exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to symptoms onset | Days until start of symptoms of COVID-19 | 14-days | 
| Disease Severity | Visual Analog Scale of rating overall symptom severity (0 = no symptoms; 10 = most severe) | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post Exposure Prophylaxis