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Assessing of the Factors Associated with Mortality Among the Patients of PLACID Trial (A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease)

25 Pages Posted: 11 Feb 2021

See all articles by Joy John Mammen

Joy John Mammen

Christian Medical College - Department of Transfusion Medicine and Immunohaematology

Snehil Kumar

Christian Medical College - Department of Transfusion Medicine and Immunohaematology

Lovely Thomas

Christian Medical College

Gunjan Kumar

Indian Council for Medical Research

Anand Zachariah

Christian Medical College - Department of Medicine

Lakshmanan Jeyaseelan

Christian Medical College

John Victor Peter

Christian Medical College - Medical Intensive Care Unit

Anup Agarwal

Indian Council for Medical Research

Aparna Mukherjee

All India Institute of Medical Sciences (AIIMS)

Pranab Chatterjee

Johns Hopkins University - Department of International Health

Tarun Bhatnagar

Indian Council of Medical Research (ICMR) - National Institute of Epidemiology

PLACID Trial Collaborators

More...

Abstract

Background: Large data on the clinical characteristics and outcome of COVID-19 in the Indian population are scarce. We analyzed the factors associated with mortality in a cohort of moderately ill COVID-19 patients enrolled in a multicentre randomized trial on convalescent plasma.

Methods: Demographic, clinical, laboratory, treatment, and outcome data were extracted from electronic records. Factors associated with mortality were explored using univariate and multivariable Cox regression analysis and expressed as hazard ratio (HR) with 95% confidence intervals (CI).

Findings: The mean (SD) age of the cohort (n=451) was 51±12·4 years; 76·7% were male. Admission SOFA score was 2·4±1·1. Non-invasive ventilation, invasive ventilation and vasopressor therapy were required in 98·9%, 8·4% and 4·0% respectively. The 28 day all-cause mortality was 14·4%. Median time from symptom onset to hospital admission was similar (p=1.0) in survivors (4 days; IQR 3-7) and non survivors (4 days; IQR 3-6). Patients with two or more co-morbidities had 2·25 (95%CI:1·17–4·32, p=0·014) times risk of death. When compared with survivors, admission IL-6 levels were higher (p<0.001) in non survivors and increased further on Day 3. On multivariable regression analysis, severity of illness (HR 1·21, 95%CI:1·07-1·36, p=0·002), PaO2/FiO2 ratio<100 (3·37, 1·54-7·41,p=0·002), Neutrophil Lymphocyte ratio (NLR)>10 (9·38, 3·67-24·0,p<0·001), D-dimer>1·0mg/l (2·51,1·14-5·51,p=0·022), ferritin>500ng/ml (2·66,1·46-4·85,p=0·001) and LDH≥450 IU/L (2·96,1·61-5·45,p=0·001) were significantly associated with death.

Interpretation: In this cohort of moderately ill COVID-19 patients, severity of illness, underlying co-morbidities and higher levels of inflammatory markers were significantly associated with death.

Trial Registration: The trial protocol was registered with the Clinical Trial Registry of India (CTRI/2020/04/024775).

Funding: This study was funded by Indian Council of Medical Research, an autonomous government funded medical research council.

Declaration of Interests: No other author has any competing financial or non-financial interest.

Ethics Approval Statement: Ethical approval was obtained from the ICMR Central Ethics Committee on Human Research 326 (CECHR-002/2020) as well as from the Institutional Review Boards (IRB) /Institutional Ethics 327 Committees of all the participating hospitals.

Suggested Citation

Mammen, Joy John and Kumar, Snehil and Thomas, Lovely and Kumar, Gunjan and Zachariah, Anand and Jeyaseelan, Lakshmanan and Peter, John Victor and Agarwal, Anup and Mukherjee, Aparna and Chatterjee, Pranab and Bhatnagar, Tarun and Trial Collaborators, PLACID, Assessing of the Factors Associated with Mortality Among the Patients of PLACID Trial (A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease). Available at SSRN: https://ssrn.com/abstract=3773515 or http://dx.doi.org/10.2139/ssrn.3773515

Joy John Mammen (Contact Author)

Christian Medical College - Department of Transfusion Medicine and Immunohaematology ( email )

Vellore, Tamil Nadu 632004
India
+91 416 228 2536 (Phone)
+91 416 223 2035 (Fax)

Snehil Kumar

Christian Medical College - Department of Transfusion Medicine and Immunohaematology ( email )

Vellore, Tamil Nadu 632004
India

Lovely Thomas

Christian Medical College ( email )

Vellore, Tamil Nadu
India

Gunjan Kumar

Indian Council for Medical Research ( email )

P.O. Box No. 4911
Ansari Nagar
New Delhi, 110029
India

Anand Zachariah

Christian Medical College - Department of Medicine ( email )

Vellore
India

Lakshmanan Jeyaseelan

Christian Medical College ( email )

Vellore, Tamil Nadu
India

John Victor Peter

Christian Medical College - Medical Intensive Care Unit ( email )

Vellore
India

Anup Agarwal

Indian Council for Medical Research ( email )

P.O. Box No. 4911
Ansari Nagar
New Delhi, 110029
India

Aparna Mukherjee

All India Institute of Medical Sciences (AIIMS) ( email )

Aurobindo Marg
Ansari Nagar East
New Delhi, New Delhi 110029
India

Pranab Chatterjee

Johns Hopkins University - Department of International Health ( email )

Baltimore, MD 21205
United States

Tarun Bhatnagar

Indian Council of Medical Research (ICMR) - National Institute of Epidemiology ( email )

Chennai, Tamil Nadu 600077
India

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