Clinical trial NCT04691921: Current Pharmacological Practices in Severe COVID-19
Official title: Nation-wide Cross-sectional Survey on Current Pharmacological Practices in Severe COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: NMC Specialty Hospital
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 1055
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Physicians involved in the clinical management of adult severe COVID-19 patients in India.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Choice and indication of pharmacological agents for management of Severe COVID-19
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Reliance Hospital
state: Mumbai, Mahrastra
Study officials:
affiliation: NMC Specialty Hospital
name: Prashant Nasa, MD EDICM
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1001/jama.2020.2648. No abstract available.
citation: 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. No abstract available.