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NCT04691921 Clinical Trial

Current Pharmacological Practices in Severe COVID-19

COVID-19 Clinical Trial

Official title:
Nation-wide Cross-sectional Survey on Current Pharmacological Practices in Severe COVID-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04691921
Other study ID # NMCSH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 4, 2021
Est. completion date January 31, 2021

Study information
Verified date February 2021
Source NMC Specialty Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aim to understand the variation in pharmacological therapies for the management of severe coronavirus disease 2019 (COVID-19) in India and compare it to the recent available evidence. The ongoing pandemic of COVID-19 has proven to be the greatest medical emergency of recent times. The evidence on the therapeutics has evolved significantly in last few months after initial use of re-purposed drugs. The objective of this study is to understand the current practices in the management of adults severe COVID-19 in India.

Description:

The ongoing pandemic of COVID-19 has proven to be the greatest medical emergency of recent times. The response of the medical world to this crisis has been unprecedented. The healthcare workers are caring for patients at the frontline while, scientists and researchers are discovering vaccines or effective treatment in shortest possible duration. The scale and effect of pandemic in India, being second most populous country of the world is enormous. As of December 30, 2020, India has crossed 10 million cases and 148,000 deaths from COVID-19. India has second most number of cases only after United States of America (USA) and with third largest number of deaths. The Ministry of Health and family Welfare (Under Government of India) has given periodical clinical management guidelines, with last updated on July 5, 2020 (version 5). In adults, severe COVID-19 is defined as presence of any of the following dyspnea, a respiratory rate of 30 or more breaths per minute, a blood oxygen saturation (SpO2) of 93% or less, a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (Pao2:Fio2) of less than 300 mm Hg, or infiltrates in more than 50% of the lung field while Critical COVID-19 is defined as presence of acute respiratory distress syndrome (ARDS), sepsis or septic shock. The mortality in critical COVID-19 is reported to be 25-49% in different studies. The evidence on the therapeutics for COVID-19 has evolved significantly in last few months after initial use of re-purposed drugs. There are no recent guidelines available based on the current evidence for clinical management of COVID-19. The investigators are planning for nation-wide multicentre cross-sectional survey on understanding participating physicians practices on choice of different pharmacotherapeutic agents available in India as of January 2021. The objective of this study is to understand the current practices of participating physicians in the management of adult patients with severe COVID-19 in India and to determine future priorities.

Recruitment information / eligibility
Status Completed
Enrollment 1055
Est. completion date January 31, 2021
Est. primary completion date January 18, 2021
Accepts healthy volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: Physicians who are involved in management of adult patients with severe COVID-19 in India Exclusion Criteria: Pediatrician Physicians who are not managing severe COVID-19 patients or refused to participate.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Current clinical practices of participating physicians
Current clinical practice of participating physicians on choice of pharmacological agents for clinical management of Severe COVID-19

Locations
Country Name City State
India Reliance Hospital Mumbai Mumbai, Mahrastra

Sponsors (1)
Lead Sponsor Collaborator
NMC Specialty Hospital

Country where clinical trial is conducted

India, 

References & Publications (2)

Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med. 2020 Dec 17;383(25):2451-2460. doi: 10.1056/NEJMcp2009575. Epub 2020 May 15. Review. — View Citation

Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Choice and indication of pharmacological agents for management of Severe COVID-19 Cross-sectional survey will capture the current choice and indication of different pharmacological agents for management of Severe COVID-19 among participating physicians in India two weeks
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