Community-based Post-exposure Prophylaxis for COVID-19

NCT04920773 | Completed DMC

• 1 other identifier: NMP/CARE/01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Keywords

Post Exposure Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Number of participants with active COVID-19

  PCR- proven COVID-19

  14-days following exposure

Secondary Outcomes (2)

• Time to symptoms onset

  14-days

• Disease Severity

  14 days

Study Arms (2)

Ayurveda Care Group

EXPERIMENTAL

Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask Samshamani vati or Giloy Ghanavati

Other: Guduchi Ghanvati; Other: Standard guidelines

Usual Care Group

ACTIVE COMPARATOR

Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask

Other: Standard guidelines

Interventions

Guduchi Ghanvati OTHER

500 mg of Samshamani vati or Giloy Ghanavati (Aqueous extract of Tinospora cordifolia) twice daily

Ayurveda Care Group

Standard guidelines OTHER

Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask

Ayurveda Care Group; Usual Care Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NMP Medical Research Institute: lead
• Aarogyam UK: collaborator
• Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University: collaborator
• Samta Ayurveda Prakoshtha, India: collaborator
• Padmanabhama Ayurveda Hospital and Research Centre: collaborator

Study Sites (2)

NMP Medical Research Institute

Jaipur, Rajasthan, India

Location

Padmnabham Ayurveda Hospital & Research Center

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Neha Sharma

  Aarogyam UK

  STUDY CHAIR

• Skanthesh Lakshmanan

  Niramaya clinic, India

  STUDY CHAIR

• Isha Goyal

  NMP Medical Research Institute, India

  PRINCIPAL INVESTIGATOR

• Abijith Venu

  Aarogyam UK

  STUDY CHAIR

• Sahil Singhal

  NMP Medical Research Institute

  STUDY DIRECTOR

• Abhimanyu Kumar

  Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 10, 2021
• Study Start: May 3, 2021
• Primary Completion: May 21, 2021
• Study Completion: June 6, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

IN (2)