tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2021 Aug 21;8(8)
fab391.
doi: 10.1093/ofid/ofab391. eCollection 2021 Aug.
Experience of Treating COVID-19 With Remdesivir and Convalescent Plasma in a Resource-Limited Setting: A Prospective, Observational Study
Janak Koirala[SUP] 1 2 [/SUP], Pradip Gyanwali[SUP] 1 [/SUP], Robert B Gerzoff[SUP] 3 [/SUP], Saroj Bhattarai[SUP] 1 [/SUP], Bipin Nepal[SUP] 4 [/SUP], Rekha Manandhar[SUP] 5 [/SUP], Runa Jha[SUP] 5 [/SUP], Sanjib Sharma[SUP] 6 [/SUP], Yuba Raj Sharma[SUP] 7 [/SUP], Anup Bastola[SUP] 8 [/SUP], Holly Murphy[SUP] 9 [/SUP], Subhash Acharya[SUP] 10 [/SUP], Prabhat Adhikari[SUP] 4 [/SUP], Manita Rajkarnikari[SUP] 11 [/SUP], Karishma M Vaidya[SUP] 5 [/SUP], Chhabi L Panthi[SUP] 1 [/SUP], Bihungum Bista[SUP] 1 [/SUP], Grishma Giri[SUP] 1 [/SUP], Shambhu Aryal[SUP] 12 [/SUP], Suman Pant[SUP] 1 [/SUP], Akritee Pokharel[SUP] 13 [/SUP], Shristi Karki[SUP] 1 [/SUP], Sangita Basnet[SUP] 2 7 [/SUP], Bhagawan Koirala[SUP] 10 [/SUP], Meghnath Dhimal[SUP] 1 [/SUP], Nepal COVID-19 Clinical Study Collaborators
Collaborators, Affiliations
Abstract
Background: Convalescent plasma therapy (CPT) and remdesivir (REM) have been approved for investigational use to treat coronavirus disease 2019 (COVID-19) in Nepal.
Methods: In this prospective, multicentered study, we evaluated the safety and outcomes of treatment with CPT and/or REM in 1315 hospitalized COVID-19 patients over 18 years in 31 hospitals across Nepal. REM was administered to patients with moderate, severe, or life-threatening infection. CPT was administered to patients with severe to life-threatening infections who were at high risk for progression or clinical worsening despite REM. Clinical findings and outcomes were recorded until discharge or death.
Results: Patients were classified as having moderate (24.2%), severe (64%), or life-threatening (11.7%) COVID-19 infection. The majority of CPT and CPT + REM recipients had severe to life-threatening infections (CPT 98.3%; CPT + REM 92.1%) and were admitted to the intensive care unit (ICU; CPT 91.8%; CPT + REM 94.6%) compared with those who received REM alone (73.3% and 57.5%, respectively). Of 1083 patients with reported outcomes, 78.4% were discharged and 21.6% died. The discharge rate was 84% for REM (n = 910), 39% for CPT (n = 59), and 54.4% for CPT + REM (n = 114) recipients. In a logistic model comparing death vs discharge and adjusted for age, gender, steroid use, and severity, the predicted margin for discharge was higher for recipients of remdesivir alone (0.82; 95% CI, 0.79-0.84) compared with CPT (0.58; 95% CI, 0.47-0.70) and CPT + REM (0.67; 95% CI, 0.60-0.74) recipients. Adverse events of remdesivir and CPT were reported in <5% of patients.
Conclusions: This study demonstrates a safe rollout of CPT and REM in a resource-limited setting. Remdesivir recipients had less severe infection and better outcomes.ClinicalTrials.gov identifier. NCT04570982.
Keywords: COVID-19; convalescent plasma; remdesivir.
. 2021 Aug 21;8(8)
fab391.doi: 10.1093/ofid/ofab391. eCollection 2021 Aug.
Experience of Treating COVID-19 With Remdesivir and Convalescent Plasma in a Resource-Limited Setting: A Prospective, Observational Study
Janak Koirala[SUP] 1 2 [/SUP], Pradip Gyanwali[SUP] 1 [/SUP], Robert B Gerzoff[SUP] 3 [/SUP], Saroj Bhattarai[SUP] 1 [/SUP], Bipin Nepal[SUP] 4 [/SUP], Rekha Manandhar[SUP] 5 [/SUP], Runa Jha[SUP] 5 [/SUP], Sanjib Sharma[SUP] 6 [/SUP], Yuba Raj Sharma[SUP] 7 [/SUP], Anup Bastola[SUP] 8 [/SUP], Holly Murphy[SUP] 9 [/SUP], Subhash Acharya[SUP] 10 [/SUP], Prabhat Adhikari[SUP] 4 [/SUP], Manita Rajkarnikari[SUP] 11 [/SUP], Karishma M Vaidya[SUP] 5 [/SUP], Chhabi L Panthi[SUP] 1 [/SUP], Bihungum Bista[SUP] 1 [/SUP], Grishma Giri[SUP] 1 [/SUP], Shambhu Aryal[SUP] 12 [/SUP], Suman Pant[SUP] 1 [/SUP], Akritee Pokharel[SUP] 13 [/SUP], Shristi Karki[SUP] 1 [/SUP], Sangita Basnet[SUP] 2 7 [/SUP], Bhagawan Koirala[SUP] 10 [/SUP], Meghnath Dhimal[SUP] 1 [/SUP], Nepal COVID-19 Clinical Study Collaborators
Collaborators, Affiliations
- PMID: 34430672
- PMCID: PMC8379705
- DOI: 10.1093/ofid/ofab391
Abstract
Background: Convalescent plasma therapy (CPT) and remdesivir (REM) have been approved for investigational use to treat coronavirus disease 2019 (COVID-19) in Nepal.
Methods: In this prospective, multicentered study, we evaluated the safety and outcomes of treatment with CPT and/or REM in 1315 hospitalized COVID-19 patients over 18 years in 31 hospitals across Nepal. REM was administered to patients with moderate, severe, or life-threatening infection. CPT was administered to patients with severe to life-threatening infections who were at high risk for progression or clinical worsening despite REM. Clinical findings and outcomes were recorded until discharge or death.
Results: Patients were classified as having moderate (24.2%), severe (64%), or life-threatening (11.7%) COVID-19 infection. The majority of CPT and CPT + REM recipients had severe to life-threatening infections (CPT 98.3%; CPT + REM 92.1%) and were admitted to the intensive care unit (ICU; CPT 91.8%; CPT + REM 94.6%) compared with those who received REM alone (73.3% and 57.5%, respectively). Of 1083 patients with reported outcomes, 78.4% were discharged and 21.6% died. The discharge rate was 84% for REM (n = 910), 39% for CPT (n = 59), and 54.4% for CPT + REM (n = 114) recipients. In a logistic model comparing death vs discharge and adjusted for age, gender, steroid use, and severity, the predicted margin for discharge was higher for recipients of remdesivir alone (0.82; 95% CI, 0.79-0.84) compared with CPT (0.58; 95% CI, 0.47-0.70) and CPT + REM (0.67; 95% CI, 0.60-0.74) recipients. Adverse events of remdesivir and CPT were reported in <5% of patients.
Conclusions: This study demonstrates a safe rollout of CPT and REM in a resource-limited setting. Remdesivir recipients had less severe infection and better outcomes.ClinicalTrials.gov identifier. NCT04570982.
Keywords: COVID-19; convalescent plasma; remdesivir.