Covid-19 living Data

Ribavirin+Lopinavir+Ritonavir+Interferon alpha vs Ribavirin+Interferon alpha (RCT)

Hospitalized patients

FOREST PLOTS -2021-04-22

Studies description

Trial ChiCTR2000029387
Publication Huang YQ, Front Pharmacol (2020) (published paper)
Dates: 29/01/2020 to 25/02/2020
Funding: Public/non profit (National Science and Technology Major Project of China During the 13th Five-year Plan Period; Chongqing Special Research Project for Prevention and Control of Novel Coronavirus Pneumonia)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / China Follow-up duration (days): 32
Inclusion criteria	(1) 18-65 years of age (2) diagnosed as mild to moderate COVID-19 and (3) willing to sign informed consent.
Exclusion criteria	(1) were pregnant or breastfeeding women (2) had aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 x upper normal limit, creatinine clearance <50 ml/min (Lu and Dong, 2019) (3) were allergic or intolerant to therapeutic drugs (4) were HIV-positive patients (5) had severe heart disease, brain disease, lung disease, kidney disease, neoplastic disease, or other systemic diseases, which may have had the potential to influence patients' adherence to the prescribed antiviral regimens and (6) withheld informed consent.
Interventions
	Treatment LPV/r+IFN alpha Lopinavir/ritonavir: 400 mg/100 mg orally twice a day for 14 days. IFN alpha: 5 MIU or 50 mg by atomizing inhalation twice a day for 14 days. RBV+LPV/r+IFN alpha RBV: 2g IV injection, followed by 400-600 mg orally 3 times a day for 14 days. Lopinavir/ritonavir: 400 mg/100 mg orally twice a day for 14 days. IFN alpha: 5 MIU or 50 mg by atomizing inhalation twice a day for 14 days.
	Control RBV+IFN alpha RBV: 2g IV injection, followed by 400-600 mg orally 3 times a day for 14 days. IFN alpha: 5 MIU or 50 mg by atomizing inhalation twice a day for 14 days.
Participants
	Randomized participants : RBV+IFN alpha=33 LPV/r+IFN alpha=36 RBV+LPV/r+IFN alpha=32
	Characteristics of participants N= 101 Mean age : NR 46 males Severity : Mild: n=0 / Moderate: n=101 / Severe: n=0 Critical: n=0
Primary outcome
	In the register The time to 2019-nCoV RNA negativity in patients
	In the report The difference in the interval from baseline (initiation of antiviral treatment) to SARS-CoV-2 nucleic acid negativity by nasopharyngeal swab among the three antiviral treatment groups, with each of these two tests at least 24 h apart.
Documents avalaible	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to all available versions of published article, the study registry and protocol were used in data extraction and risk bias assessment. Sample size specified in the registry was not achieved due to "scarcity of appropriate patients to recruit". There is no change from the trial registration in the intervention and control treatments. There is no change from the trial registration in primary and secondary outcomes. The trialists used as primary outcome "SARS-CoV-2 nucleic acid negativity" defined as "presence of negative SARS-COV-2 results in at least two consecutive nasopharyngeal swabs by reverse transcriptase polymerase chain reaction (RT-PCR), with an interval of at least 24 h between the two time points of swab-taking" which we interpreted as "negative conversion". Response from contact with authors was received on September 7th 2020, and data were updated accordingly.