Community-based Post-exposure Prophylaxis for COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Guduchi Ghanvati; Other: Standard guidelines

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Jaipur, Rajasthan, India
      • NMP Medical Research Institute
    • Jaipur, Rajasthan, India
      • Padmnabham Ayurveda Hospital & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: NMP Medical Research Institute
• Collaborators: Aarogyam UK; Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University; Samta Ayurveda Prakoshtha, India; Padmanabhama Ayurveda Hospital and Research Centre
• Investigators: Study Chair: Neha Sharma, Aarogyam UK; Study Chair: Skanthesh Lakshmanan, Niramaya clinic, India; Principal Investigator: Isha Goyal, NMP Medical Research Institute, India; Study Chair: Abijith Venu, Aarogyam UK; Study Director: Sahil Singhal, NMP Medical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): May 21, 2021
• Study Completion (Actual): June 6, 2021

Study Registration Dates

• First Submitted: June 6, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Post Exposure Prophylaxis
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: NMP/CARE/01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No