Table 2.

Antivirals currently under clinical trials. IAV, influenza A virus; IBV, influenza B virus; ICU, intensive care unit; LRTI, lower respiratory tract infection; SARI, severe acute respiratory infection; URTI, upper respiratory tract infection. Source: ClinicalTirals.gov.

Antiviral	Title	Trial #	Target population	Outcome measurements	Phase	Research group/institution	Locations
Oseltamivir	Quantification of Viral Load in the Upper Respiratory Tract in Patients Treated with Oseltamivir for Influenza	NCT04515446	In‐patient adults (≥ 18 years) admitted for influenza and treated with oseltamivir	Primary: Duration of virus shedding by type IAV or IBV Secondary: Duration of virus shedding by vaccination status and comorbidities. Difference in number of days in isolation between hospitalize patients treated with oseltamivir	N/A	Centre Hospitalier Princesse Grace	Monaco
Oseltamivir vs. Paracetamol	Oseltamivir Versus Paracetamol for Influenza‐like Illness During the Influenza Season	NCT03754686	Adults (≥ 18 years) hospitalized during high season with SARI	Primary: Failure to reach clinical stability, transfer to ICU, readmission within 30 days or death within 30 days Secondary: Time to clinical stability and duration of hospitalization	IV	Rambam Health Care Campus	N/A
N‐acetyl cysteine + Oseltamivir or 5% Dextrose + Oseltamivir	Intravenous N‐acetylcysteine and Oseltamivir Versus Oseltamivir in Adults Hospitalized with Influenza and Pneumonia	NCT03900988	Adults hospitalized with influenza complicated by LRTI	Primary: Normalization of respiratory status in days (oxygen saturation and respiratory rate) Secondary: Copies of viral RNA. Levels of interleukins 6, 8, 17, and 18, chemokine ligand 9, sTNFR‐1, CRP, phospho‐p38 and phospho‐ERK, phospho‐inhibitor kB/IkB. Resolution of symptoms in days. ICU admission. Mortality in days. Incidence of treatment‐emergent adverse events	IV	Chinese University of Hong Kong	N/A
Sirolimus + Oseltamivir vs. Oseltamivir	Adjunctive Sirolimus and Oseltamivir Versus Oseltamivir Alone for Treatment of Influenza	NCT03901001	Adults (≥ 18 years) positive for IAV or IBV and hospitalized with complicated LRTI	Primary: Normalization of respiratory status in days (oxygen saturation and respiratory rate) Secondary: Copies of viral RNA. Levels of interleukins 6, 8, 17, and 18, chemokine ligand 9, sTNFR‐1, CRP, phospho‐p38 and phospho‐ERK, phospho‐inhibitor kB/IkB. Resolution of symptoms in days. ICU admission. Mortality in days. Incidence of treatment‐emergent adverse events	IV	Chinese University of Hong Kong	N/A
Baloxavir	Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants from Birth to < 1 Year with Influenza‐Like Symptoms	NCT03653364	Infants (≤ 1 year) positive and symptomatic for influenza infection	Primary: % of participants with side effects and severe side effects Secondary: Drug pharmacokinetics. Time to alleviation of influenza signs and symptoms. Duration of fever and symptoms. Time to return to normal health and activity. Frequency of influenza‐related complications. % Requiring antibiotics. Duration of virus shedding. Virus titers	III	Hoffman‐La Roche	USA, Costa Rica, Mexico, Finland, Israel, Panama, Poland, Russia South Africa, Spain, Thailand
Baloxavir vs. Placebo	Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households	NCT03969212	Individuals (5–64 years) positive for influenza virus and negative for SARS‐CoV‐2. Leaving in a household with people negative for influenza or SARS‐CoV‐2	Primary: Virus transmission by day 5 postrandomization Secondary: Virus and symptomatic transmission by day 5 and 9 postrandomization. % of index patients with adverse effects. Change in productivity and activity impairment in index patients only	III	Hoffman‐La Roche	USA, Argentina, Brazil, Bulgaria, Chile, China, Costa Rica, France, Greece, Hong Kong, Hungary, India, Israel, Japan, Mexico, New Zealand, Poland, Singapore, South Africa, Spain, Turkey, UK
Oseltamivir + Baloxavir vs. Oseltamivir + Placebo	Combination Therapy with Baloxavir and Oseltamivir 1 for Hospitalized Patients with Influenza (The COMBO Trial 1)	NCT04327791	Adults (≥ 18 years) with laboratory confirmed IAV or IBV infection	Primary: Time to clearance of viral shedding	II, III	Bassett Healthcare; Genentech, Inc.; Viroclinics Biosciences B.V.	USA
Baloxavir vs. Oseltamivir	Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks	NCT05012189	Adult (≥ 18 years) nursing home residents and staff	Primary: Number of ILI cases after randomization Secondary: Outbreak duration. Number of antiviral course treatments needed to control the outbreak per facility. Respiratory‐related hospitalizations in residents ≥ 65 years old during influenza season 2021‐2021 after randomization. Mortality rate after randomization	IV	Insight Therapeutics, LLC; Brown University; Case Western Reserve University; Genentech, Inc.	USA
Baloxavir + Oseltamivir vs. Oseltamivir	Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients	NCT04712539	Influenza‐positive patients, recipient of hematopoietic cell transplants or have a hematological malignancy. Evidence of LRTI or high risk of URTI	Primary: Changes in viral loads. Incidence of complicated hospital stay Secondary: Antiviral resistance rate. Progression to LRTI. Length of hospital stay. Oxygen requirement. Rate of respiratory failure. Morality rate. Changes in microbiome diversity	II	M.D. Anderson Cancer Center	USA
ZSP1273 + Oseltamivir placebo vs. Oseltamivir + ZSP1273 placebo	A Study of ZSP1273 Tablets in Patients with Acute Uncomplicated Influenza A	NCT04683406	Adults (≥ 18 to ≤ 64 years) positive for influenza infection	Primary: Time to alleviation of symptoms Secondary: Antiviral resistance rate. % of participants with virus titers. % of participants with detectable viral RNA. Duration of virus shedding. % of participants with alleviated symptoms. Time to alleviation of symptoms. % of participants with influenza‐related complications	III	Guangdong Raynovent Biotech Co., Ltd	China, at 73 locations
Reduning + Oseltamivir Phosphate granules simulants vs. Oseltamivir Phosphate granules + Reduning simulants	Clinical Study of Reduning Injection for the Treatment of Influenza in Children	NCT04183725	Children (2–14 years) positive for influenza	Primary: Time to temperature recovery Secondary: Time to alleviation of symptoms. Degree of disease remission. Rate of negative for influenza testing. Number and frequency of antipyretic/analgesic drugs used. Incidence of complications	IV	China Academy of Chinese Medical Sciences; Children's Hospital of Soochow University; Anhui Provincial Children's Hospital; Qilu Children's Hospital of Shandong University; Tianjin 4th Centre Hospital; Renmin Hospital of Wuhan University; Hebei Maternity&Child Healthcare Hospital; The Second Affiliated Hospital of Jiaxing University; The First Hospital of Hunan University of Chinese Medicine; Affiliated Hospital of Shanxi University of Traditional Chinese Medicine	N/A
HEC116094 vs. Oseltamivir vs. HEC11609 + Oseltamivir	Single Dose and Multiple Dose Safety, Tolerability, PK and Food Effect Study and Interaction with Oseltamivir Study of HEC116094 in Healthy Adult Subjects	NCT04982913	Healthy adults (18–45 years)	Primary: Safety and tolerability. Secondary: Drug pharmacokinetics	I	Sunshine Lake Pharma Co., Ltd.	China
Zanamivir	An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants with Influenza Infection	NCT04494412	Neonates and infants (≤ 6 months) with influenza infection	Primary: Drug pharmacokinetics. Secondary: Adverse effects. Number of participants with abnormal findings in temperature, respiratory rate, oxygen saturation, heart rate. Number of participants with phenotypic and genotypic resistance. Number of patients with resistance emergence. Virus load over time	II	Glaxo Smith Kline	Poland, Spain
GP681 tables vs. GP681 simulants	A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza	NCT04736758	Adults (18–65 years) with symptomatic influenza infection	Primary: Time to alleviation of influenza symptoms	II	Jiangxi Qingfeng Pharmaceutical Co. Ltd.	China
TG‐1000 vs. Placebo	To Evaluate the Efficacy and Safety of TG‐1000 Compared with Placebo in Adult Patients with Acute Uncomplicated Influenza Virus Infection	NCT04706468	Adults (18–65 years) with uncomplicated influenza infection	Primary: Drug antiviral activity vs the placebo Secondary: Time to alleviation of symptoms. % Of patients positive for viral RNA. Time to resolution of fever. Time to return to preinfluenza status. Body temperature. Incidence of influenza‐related complications	II	TaiGen Biotechnology Co.; Ltd. R&G Pharma Studies Co., Ltd.	China