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Anti-Infective Agents


ISSN (Print): 2211-3525
ISSN (Online): 2211-3533

Clinical Trial

Comparison of Efficacy of Remdesivir with Supportive Care Alone in the Treatment of Critically Sick Adult and Child COVID-19 Patients: A Randomized Clinical Trial

Author(s): Ahmad Hormati, Sajjad Ahmadpour, Mohammad Reza Ghadir, Seyed Yaser Foroghi Ghomi, Javad Tafaroji, Zahra Movahedi, Seyed Kamal Eshagh Hossaini, Morteza Khoshgoftar and Mina Gheitani*

Volume 21, Issue 1, 2023

Published on: 12 September, 2022

Article ID: e170522204883 Pages: 7

DOI: 10.2174/2211352520666220517092803

Price: $65


Background: Seeking new specific and effective drugs against Coronavirus Diseases-2019 (COVID-19) is of great importance. This study describes the efficacy of remdesivir with supportive care alone in the treatment of critically sick adult and child COVID-19 patients.

Methods: This study was a one-blind placebo-controlled, randomized clinical trial in adults (aged≥18 years) and children (aged≤12 years) in Iran. Patients were included if they had positive PCR test for SARS-CoV-2 infection, O2 saturation ≤88%, and compatible symptoms. All participants received standard care following national treatment guidelines. The treatment group received remdesivir (200 mg IV on day 1 and followed by 100 mg in single daily infusions). The control group received standard care and an identical volume of placebo infusions (Water for injection) for 5 days. For pediatric patients, the intervention group received remdesivir (5mg/kg on the first day and then 5.2 mg/kg on days 2 to 5). Discharge from the hospital within 10 days of first treatment is considered as the primary endpoint of the study. Admission in the intensive care unit (ICU) is considered as original secondary endpoint of the study.

Results: 141 patients were enrolled and randomly assigned to two group (adults; 54 patients in the intervention group vs. 52 patients in the control group, and children; 17 patients in the intervention group vs. 18 patients in the control group). The mean time from the first symptoms until the referral to the hospital in adult patients was 5.61 ± 2.67 day and 4.80±1.48 day for intervention and control groups, respectively. The mean time from the first symptoms until death was reported to be significant and was longer for intervention group than the control group (24.83 ± 11.25 vs. 10.50 ± 2.42 day; p value=0. 012). For children who received remdesivir, the mean time between admission until death was reported to be significant, as the finding highlighted a longer time duration for the intervention group (13.55 ± 0.72 vs. 10.66 ± 0.57 day; p value=0. Mechanicalanical ventilation was used in 17 patients (100%) and 18 patients (100%) in the intervention and control groups, respectively (p value=0.853).

Conclusion: Among patients with critical COVID-19, those randomized to a 5-day treatment of remdesivir did have a statistically significant difference in clinical status compared with the control group of both adults and children.

Keywords: Infectious disease, COVID-19, mechanical ventilation, treatment, remdesivir, PCR test.

Chen, H.; Guo, J.; Wang, C.; Luo, F.; Yu, X.; Zhang, W.; Li, J.; Zhao, D.; Xu, D.; Gong, Q.; Liao, J.; Yang, H.; Hou, W.; Zhang, Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: A retrospective review of medical records. Lancet, 2020, 395(10226), 809-815.
[] [PMID: 32151335]
Zhu, N.; Zhang, D.; Wang, W.; Li, X.; Yang, B.; Song, J.; Zhao, X.; Huang, B.; Shi, W.; Lu, R.; Niu, P.; Zhan, F.; Ma, X.; Wang, D.; Xu, W.; Wu, G.; Gao, G.F.; Tan, W. A novel coronavirus from patients with pneumonia in China, 2019. N. Engl. J. Med., 2020, 382(8), 727-733.
[] [PMID: 31978945]
Barry, M.; AlMohaya, A.; AlHijji, A.; Akkielah, L.; AlRajhi, A.; Almajid, F.; Alsharidi, A.; Al-Shahrani, F.S.; Alotaibi, N.H.; Alanazi, A.; Ghonem, L.; Alhetheel, A.; Alsubaie, S.; Memish, Z.A. Clinical characteristics and outcome of hospitalized COVID-19 patients in a MERS-CoV endemic area. J. Epidemiol. Glob. Health, 2020, 10(3), 214-221.
[] [PMID: 32954712]
Dong, X.; Cao, Y.Y.; Lu, X.X.; Zhang, J.J.; Du, H.; Yan, Y.Q.; Akdis, C.A.; Gao, Y.D. Eleven faces of coronavirus disease 2019. Allergy, 2020, 75(7), 1699-1709.
[] [PMID: 32196678]
Yang, Z.; Yu, M.; Li, G.; Dai, X.; Liu, G.; Xie, J.; Li, G.; Jie, Y. A convalescent of COVID-19 with RT-PCR test continues positive in Stool. Clin. Lab., 2020, 66(12)
[] [PMID: 33337843]
Hormati, A.; Ghadir, M.R.; Zamani, F.; Khodadadi, J.; Afifian, M.; Ahmadpour, S. Preventive strategies used by GI physicians during the COVID-19 pandemic. New Microbes New Infect., 2020, 35, 100676.
[] [PMID: 32292589]
Jee, Y. WHO international health regulations emergency committee for the COVID-19 outbreak. Epidemiol. Health, 2020, 42, e2020013.
[] [PMID: 32192278]
Sinha, S.; Sehgal, A.; Sehgal, R. Association of ACE2 receptor and ACEIs/ARBs with disease severity in COVID-19. Drug Discov. Ther., 2020, 14(4), 161-170.
[] [PMID: 32908071]
Sokolowska, M.; Lukasik, Z.M.; Agache, I.; Akdis, C.A.; Akdis, D.; Akdis, M.; Barcik, W.; Brough, H.A.; Eiwegger, T.; Eljaszewicz, A.; Eyerich, S.; Feleszko, W.; Gomez-Casado, C.; Hoffmann-Sommergruber, K.; Janda, J.; Jiménez-Saiz, R.; Jutel, M.; Knol, E.F.; Kortekaas Krohn, I.; Kothari, A.; Makowska, J.; Moniuszko, M.; Morita, H.; O’Mahony, L.; Nadeau, K.; Ozdemir, C.; Pali-Schöll, I.; Palomares, O.; Papaleo, F.; Prunicki, M.; Schmidt-Weber, C.B.; Sediva, A.; Schwarze, J.; Shamji, M.H.; Tramper-Stranders, G.A.; van de Veen, W.; Untersmayr, E. Immunology of COVID-19: Mechanisms, clinical outcome, diagnostics, and perspectives-A report of the European Academy of Allergy and Clinical Immunology (EAACI). Allergy, 2020, 75(10), 2445-2476.
[] [PMID: 32584441]
Zhao, H.; Lu, L.; Peng, Z.; Chen, L-L.; Meng, X.; Zhang, C.; Ip, J.D.; Chan, W-M.; Chu, A.W-H.; Chan, K-H.; Jin, D.Y.; Chen, H.; Yuen, K.Y.; To, K.K. SARS-CoV-2 Omicron variant shows less efficient replication and fusion activity when compared with Delta variant in TMPRSS2-expressed cells. Emerg. Microbes Infect., 2022, 11(1), 277-283.
[] [PMID: 34951565]
Tyagi, S.C.; Singh, M. Multi-organ damage by COVID-19: Congestive (cardio-pulmonary) heart failure, and blood-heart barrier leakage. Mol. Cell. Biochem., 2021, 476(4), 1891-1895.
[] [PMID: 33483858]
Zimmermann, P.; Curtis, N. Why is COVID-19 less severe in children? A review of the proposed mechanisms underlying the age-related difference in severity of SARS-CoV-2 infections. Arch. Dis. Child., 2020, 106(5), 429-439.
[] [PMID: 33262177]
Castagnoli, R.; Votto, M.; Licari, A.; Brambilla, I.; Bruno, R.; Perlini, S.; Rovida, F.; Baldanti, F.; Marseglia, G.L. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in children and adolescents: A systematic review. JAMA Pediatr., 2020, 174(9), 882-889.
[] [PMID: 32320004]
Hormati, A.; Ghadir, M.R.; Zamani, F.; Khodadadi, J.; Khodadust, F.; Afifian, M.; Aminnejad, R.; Ahmadpour, S. Are there any association between COVID-19 severity and immunosuppressive therapy? Immunol. Lett., 2020, 224, 12-13.
[] [PMID: 32473971]
Patel, B.; Sharma, S.; Nair, N.; Majeed, J.; Goyal, R.K.; Dhobi, M. Therapeutic opportunities of edible antiviral plants for COVID-19. Mol. Cell. Biochem., 2021, 476(6), 2345-2364.
[] [PMID: 33587232]
Choi, H.M.; Moon, S.Y.; Yang, H.I.; Kim, K.S. Understanding viral infection mechanisms and patient symptoms for the development of COVID-19 therapeutics. Int. J. Mol. Sci., 2021, 22(4), 1737.
[] [PMID: 33572274]
George, P.M.; Wells, A.U.; Jenkins, R.G. Pulmonary fibrosis and COVID-19: The potential role for antifibrotic therapy. Lancet Respir. Med., 2020, 8(8), 807-815.
[] [PMID: 32422178]
Beigel, J.H.; Tomashek, K.M.; Dodd, L.E.; Mehta, A.K.; Zingman, B.S.; Kalil, A.C.; Hohmann, E.; Chu, H.Y.; Luetkemeyer, A.; Kline, S.; Lopez de Castilla, D.; Finberg, R.W.; Dierberg, K.; Tapson, V.; Hsieh, L.; Patterson, T.F.; Paredes, R.; Sweeney, D.A.; Short, W.R.; Touloumi, G.; Lye, D.C.; Ohmagari, N.; Oh, M.D.; Ruiz-Palacios, G.M.; Benfield, T.; Fätkenheuer, G.; Kortepeter, M.G.; Atmar, R.L.; Creech, C.B.; Lundgren, J.; Babiker, A.G.; Pett, S.; Neaton, J.D.; Burgess, T.H.; Bonnett, T.; Green, M.; Makowski, M.; Osinusi, A.; Nayak, S.; Lane, H.C. Remdesivir for the Treatment of Covid-19 - Final Report. N. Engl. J. Med., 2020, 383(19), 1813-1826.
[] [PMID: 32445440]
Méndez-Echevarría, A.; Pérez-Martínez, A.; Gonzalez Del Valle, L.; Ara, M.F.; Melendo, S.; Ruiz de Valbuena, M.; Vazquez-Martinez, J.L.; Morales-Martínez, A.; Remesal, A.; Sándor-Bajusz, K.A.; Cabañas, F.; Calvo, C. Compassionate use of remdesivir in children with COVID-19. Eur. J. Pediatr., 2021, 180(4), 1317-1322.
[] [PMID: 33200304]
Frauenfelder, C.; Brierley, J.; Whittaker, E.; Perucca, G.; Bamford, A. Infant with SARS-CoV-2 infection causing severe lung disease treated with remdesivir. Pediatrics, 2020, 146(3), e20201701.
[] [PMID: 32554811]
Yalçın, N.; Demirkan, K. COVID-19 and remdesivir in pediatric patients: The invisible part of the iceberg. Pediatr. Res., 2021, 89(6), 1326-1327.
[] [PMID: 32814341]
Xu, J.; Ma, X-P.; Bai, L.; Wang, M.; Deng, W.; Ning, N. A systematic review of etiology, epidemiology, clinical manifestations, image findings, and medication of 2019 Corona Virus Disease-19 in Wuhan, China. Medicine (Baltimore), 2020, 99(42), e22688.
[] [PMID: 33080715]
Ye, G.; Pan, Z.; Pan, Y.; Deng, Q.; Chen, L.; Li, J.; Li, Y.; Wang, X. Clinical characteristics of severe acute respiratory syndrome coronavirus 2 reactivation. J. Infect., 2020, 80(5), e14-e17.
[] [PMID: 32171867]
Chen, N.; Zhou, M.; Dong, X.; Qu, J.; Gong, F.; Han, Y.; Qiu, Y.; Wang, J.; Liu, Y.; Wei, Y.; Xia, J.; Yu, T.; Zhang, X.; Zhang, L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: A descriptive study. Lancet, 2020, 395(10223), 507-513.
[] [PMID: 32007143]
Hormati, A.; Ghadir, M.R.; Saeidi, M.; Aminnejad, R.; Khodadust, F.; Afifian, M.; Ahmadpour, S. Dysentery as a rare GI symptom found in COVID-19 patients. Gastroenterol. Hepatol., 2021, 44(1), 31-34.
[] [PMID: 32711958]
Saqrane, S.; El Mhammedi, M.A.; Lahrich, S.; Laghrib, F.; El Bouabi, Y.; Farahi, A.; Bakasse, M. Recent knowledge in favor of remdesivir (GS-5734) as a therapeutic option for the COVID-19 infections. J. Infect. Public Health, 2021, 14(5), 655-660.
[] [PMID: 33857725]
Wang, Y.; Zhang, D.; Du, G.; Du, R.; Zhao, J.; Jin, Y.; Fu, S.; Gao, L.; Cheng, Z.; Lu, Q.; Hu, Y.; Luo, G.; Wang, K.; Lu, Y.; Li, H.; Wang, S.; Ruan, S.; Yang, C.; Mei, C.; Wang, Y.; Ding, D.; Wu, F.; Tang, X.; Ye, X.; Ye, Y.; Liu, B.; Yang, J.; Yin, W.; Wang, A.; Fan, G.; Zhou, F.; Liu, Z.; Gu, X.; Xu, J.; Shang, L.; Zhang, Y.; Cao, L.; Guo, T.; Wan, Y.; Qin, H.; Jiang, Y.; Jaki, T.; Hayden, F.G.; Horby, P.W.; Cao, B.; Wang, C. Remdesivir in adults with severe COVID-19: A randomised, double-blind, placebo-controlled, multicentre trial. Lancet, 2020, 395(10236), 1569-1578.
[] [PMID: 32423584]
Beigel, J.H.; Tomashek, K.M.; Dodd, L.E.; Mehta, A.K.; Zingman, B.S.; Kalil, A.C.; Hohmann, E.; Chu, H.Y.; Luetkemeyer, A.; Kline, S.; Lopez de Castilla, D.; Finberg, R.W.; Dierberg, K.; Tapson, V.; Hsieh, L.; Patterson, T.F.; Paredes, R.; Sweeney, D.A.; Short, W.R.; Touloumi, G.; Lye, D.C.; Ohmagari, N.; Oh, M.D.; Ruiz-Palacios, G.M.; Benfield, T.; Fätkenheuer, G.; Kortepeter, M.G.; Atmar, R.L.; Creech, C.B.; Lundgren, J.; Babiker, A.G.; Pett, S.; Neaton, J.D.; Burgess, T.H.; Bonnett, T.; Green, M.; Makowski, M.; Osinusi, A.; Nayak, S.; Lane, H.C. Remdesivir for the treatment of Covid-19—preliminary report. N. Engl. J. Med., 2020, 383(19), 1813-1826.
[] [PMID: 32445440]
Baracco, GJ 2021.
Saint-Raymond, A.; Sato, J.; Kishioka, Y.; Teixeira, T.; Hasslboeck, C.; Kweder, S.L. Remdesivir emergency approvals: A comparison of the U.S., Japanese, and EU systems. Expert Rev. Clin. Pharmacol., 2020, 13(10), 1095-1101.
[] [PMID: 32909843]
Grein, J.; Ohmagari, N.; Shin, D.; Diaz, G.; Asperges, E.; Castagna, A.; Feldt, T.; Green, G.; Green, M.L.; Lescure, F-X.; Nicastri, E.; Oda, R.; Yo, K.; Quiros-Roldan, E.; Studemeister, A.; Redinski, J.; Ahmed, S.; Bernett, J.; Chelliah, D.; Chen, D.; Chihara, S.; Cohen, S.H.; Cunningham, J.; D’Arminio Monforte, A.; Ismail, S.; Kato, H.; Lapadula, G.; L’Her, E.; Maeno, T.; Majumder, S.; Massari, M.; Mora-Rillo, M.; Mutoh, Y.; Nguyen, D.; Verweij, E.; Zoufaly, A.; Osinusi, A.O.; DeZure, A.; Zhao, Y.; Zhong, L.; Chokkalingam, A.; Elboudwarej, E.; Telep, L.; Timbs, L.; Henne, I.; Sellers, S.; Cao, H.; Tan, S.K.; Winterbourne, L.; Desai, P.; Mera, R.; Gaggar, A.; Myers, R.P.; Brainard, D.M.; Childs, R.; Flanigan, T. Compassionate use of remdesivir for patients with severe Covid-19. N. Engl. J. Med., 2020, 382(24), 2327-2336.
[] [PMID: 32275812]
Antinori, S.; Cossu, M.V.; Ridolfo, A.L.; Rech, R.; Bonazzetti, C.; Pagani, G.; Gubertini, G.; Coen, M.; Magni, C.; Castelli, A.; Borghi, B.; Colombo, R.; Giorgi, R.; Angeli, E.; Mileto, D.; Milazzo, L.; Vimercati, S.; Pellicciotta, M.; Corbellino, M.; Torre, A.; Rusconi, S.; Oreni, L.; Gismondo, M.R.; Giacomelli, A.; Meroni, L.; Rizzardini, G.; Galli, M. Compassionate remdesivir treatment of severe Covid-19 pneumonia in intensive care unit (ICU) and Non-ICU patients: Clinical outcome and differences in post-treatment hospitalisation status. Pharmacol. Res., 2020, 158, 104899.
[] [PMID: 32407959]
Spinner, C.D.; Gottlieb, R.L.; Criner, G.J.; Arribas López, J.R.; Cattelan, A.M.; Soriano Viladomiu, A.; Ogbuagu, O.; Malhotra, P.; Mullane, K.M.; Castagna, A.; Chai, L.Y.A.; Roestenberg, M.; Tsang, O.T.Y.; Bernasconi, E.; Le Turnier, P.; Chang, S.C.; SenGupta, D.; Hyland, R.H.; Osinusi, A.O.; Cao, H.; Blair, C.; Wang, H.; Gaggar, A.; Brainard, D.M.; McPhail, M.J.; Bhagani, S.; Ahn, M.Y.; Sanyal, A.J.; Huhn, G.; Marty, F.M. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: A randomized clinical trial. JAMA, 2020, 324(11), 1048-1057.
[] [PMID: 32821939]

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