A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19

SARS-CoV-2 Infection Clinical Trial

— SCORPIO-HR  

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, 24-Week Study of the Clinical and Antiviral Effect of S-217622 Compared With Placebo in Non-Hospitalized Participants With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305547
• Other study ID #: ACTIV-2d/A5407
• Status: Completed
• Phase: Phase 3
• Start date: August 3, 2022
• Est. completion date: May 24, 2024

Study information

• Verified date: June 2024
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2093
• Est. completion date: May 24, 2024
• Est. primary completion date: January 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (for example, reverse-transcriptase PCR) or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP or nasal swab, or saliva) collected =72 hours (3 days) prior to randomization.

• Participants are expected to begin study intervention =3 days from self-reported date of onset of any of the COVID-19-related symptoms from the following list:

• Cough

• Shortness of breath or difficulty breathing

• Feeling feverish

• Chills

• Fatigue

• Body pain or muscle pain or aches

• Diarrhea

• Nausea

• Vomiting

• Headache

• Sore throat

• Nasal obstruction or congestion

• Nasal discharge

• Loss of taste

• Loss of smell

• One or more of the following signs/symptoms present within 24 hours prior to randomization:

• Cough

• Shortness of breath or difficulty breathing

• Feeling feverish

• Chills

• Fatigue

• Body pain or muscle pain or aches

• Diarrhea

• Nausea

• Vomiting

• Headache

• Sore throat

• Nasal obstruction or congestion

• Nasal discharge

• Participants at higher risk of progression to severe COVID-19 are defined as follows:

• Age =65 years

• Age =18 with 1 of the following:

• Obesity (body mass index [BMI] =30 kilograms per square meter [kg/m^2]). Note: BMI is rounded to the nearest whole number, for example 29.5 kg/m^2 is rounded to 30 kg/m^2.

• Diabetes mellitus

• Hypertension requiring daily prescribed therapy

• Cardiovascular disease (requiring daily prescribed therapy or congenital heart disease)

• Chronic lung disease (for example, chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) requiring daily prescribed therapy

• Chronic kidney disease, defined as known current kidney impairment with a creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) <60 milliliters (mL)/minute (min)/1.73 square meter (m^2) within the past 12 months prior to randomization, as long as the participant does not have known CrCl <30 mL/min by Cockcroft-Gault or require dialysis

• Down syndrome

• Sickle cell disease

• One of the following immunocompromising conditions or immunosuppressive treatments:

• Receiving chemotherapy or other therapies for cancer

• Hematologic malignancy (active or in remission)

• History of a hematopoietic stem cell or a solid organ transplant

• Human immunodeficiency virus infection: not on antiretroviral therapy or with cluster of differentiation 4+ cell count <200 cells per cubic millimeter

• Combined primary immunodeficiency disorder

• Taking immunosuppressive medications (for example, drugs to suppress rejection of transplanted organs or to treat rheumatologic and gastrointestinal conditions, such as anti-tumor necrosis factor agents, mycophenolate, and rituximab).

Note: Current use of some corticosteroids is exclusionary, due to concern for possible drug-drug interaction (DDI) with S-217622.

Exclusion Criteria:

• History of hospitalization for the current SARS-CoV-2 infection (that is, prior hospitalization for a prior episode of SARS-CoV-2 infection is allowable)

• For the current SARS-CoV-2 infection, any positive SARS-CoV-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP, or nasal swab, or saliva) collected ?72 hours (3 days) prior to randomization. Participants with reinfection, defined as prior SARS-CoV-2 infection that began >90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 3 days prior to randomization.

• Current need for hospitalization or immediate medical attention in the opinion of the investigator

• Current use of any medications prohibited with the study intervention. Individuals who have used Paxlovid or any other oral, inhaled, or injectable medication intended to treat the current SARS-CoV-2 infection before randomization are excluded. After randomization, locally available SARS-CoV-2 treatment (including but not limited to molnupiravir, mAbs, outpatient IV remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for DDIs.

Note: Paxlovid use for a prior episode of COVID-19 is permitted.

• Receipt of any investigational treatments for the current episode of SARS-CoV-2 at any time prior to randomization is exclusionary. Note: This does not include drugs approved for other uses and taken for those indications or COVID-19 vaccines. Note: Use of locally authorized or approved therapies to prevent COVID-19, such as mAbs given solely to prevent COVID-19, are not exclusionary.

• Any co-morbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization

• Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622

• Known (within 12 months prior to randomization) renal impairment defined as CrCl <30 mL/min by Cockcroft-Gault or requiring dialysis

• Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy)

• Participants who have used any of the following drugs within 14 days prior to randomization:

• Strong cytochrome P453A (CYP 3A) inhibitor

• Strong CYP3A inducer

• Products containing St. John's Wort

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Drug:
• S-217622
Administered as a round tablet.
• Placebo
Administered as a round tablet.

Locations

Country	Name	City	State
Argentina	Centro Privado de Medicina Familiar, Mindout Research	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Sanatorio De La Trinidad, Mitre Bartolome Mitre	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Sanatorio Allende, Av.	Cordoba
Argentina	Centro De Investigaciones	Mar De Plata	Buenos Aires
Argentina	Sanatorio Privado ,Duarte Quiros	Quiros	Cordoba
Argentina	DIM Clínica Privada, Belgrano 136 - 5to piso	Ramos Mejía	Buenos Aires
Argentina	Hospital General Agudos Dr. J.M., Grl Justo José de Urquiza 609 2do piso, Pabellón Clínica Médica, Enf. Emergentes	Ramos Mejía	Buenos Aires
Argentina	Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, Rosario	Rosario	Sante Fe
Argentina	Clinica Mayo UMCB	San Miguel de Tucuman	Tucuman
Argentina	Mendoza 2612, Rosario	Santa Fe
Argentina	Clínicas Zárate, F. Andrade 332	Zarate	Buenos Aires
Brazil	Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela	Baretos	Sao Paulo
Brazil	Faculdade de Medicina da univ., Federal, Av Alfredo Balena, 190, 1° andar - sala 161	Belo Horizonte	Minas Gerais
Brazil	Unid Pesquisa Clínica Facultad Medicina, de Botucatu UNESP, Rua Prof. Dr. Armando,Alves s/n, Distrito de rubião Junior	Botucatu	Sao Paulo
Brazil	Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis	Bragança Paulista	Sao Paulo
Brazil	Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas	Campinas
Brazil	Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo	Campinas	Sao Paolo
Brazil	AMB3 Servicos Medicos Ltda Rua Campinas	Cuiabá	Mato Grosso
Brazil	Hosp Nossa Senhora das Gracas, Rue Alcides Munhoz	Curitiba	Paraná
Brazil	Cecip Jau	Jau	Sao Paolo
Brazil	Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano Peixoto	Natal	Rio Grande Do Norte
Brazil	IPARGS, Rua Antonio Joaquim Mesquita	Porto Alegre	Rio Grande Do Sul
Brazil	Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C	Porto Alegre	Rio Grande Do Sul,
Brazil	IBPClin, Rua da Gloria	Rio de Janeiro
Brazil	INI/Fiocruz	Rio de Janeiro
Brazil	Pesquisare Saude	Santo André	Sao Paulo
Brazil	Instituto de Molestast Cardiovasculares	Tatui	Sao Paolo
Colombia	Fundación Cardiomet Cequin,, Street 18 North # 14-25,	Armenia	Quindío
Colombia	Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120	Barranquilla	Atlantico
Colombia	Corazon IPS S.A.S, Carrera 49 No 74 - 158	Barranquilla	Atlantico
Colombia	IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49	Barranquilla	Atlántico
Colombia	BlueCare Salud SAS	Bogota
Colombia	Centro de investigación en Reumatología, y Especialidades Medicas S.A.S, CIREEM S.A.S.-Cra. 12#97-32	Bogota	Bogotá
Colombia	Fundación Centro Excelencia en Enferm., Crónicas No Transmisibles-FUNCENTRA, CRA 3 N°21 44 B,	Chuchurubi Monteria	Cordoba
Colombia	Programa de estudios y control de, enfermedades tropicales PECET, Carrera 53 N°61-30 Torre 2, Lab. 632	Medellín	Antioquia
Colombia	TyC Inversiones SAS Grupsalud 33-6 IPS, Avenida Libertador # 30-360, Barrio San Pedro Alejandrino	Santa Marta	Magdalena
Ghana	Kintampo Health Research Cntr	Kintampo
Ghana	Kumasi Centre for Research, South End Asuogya Road, Kwame Nkrumah University	Kumasi
Ghana	Navrongo Health Research Cntr	Upper East	Navrongo
India	Sangini Hospital 1st Flr & 7th flr	Ahmedabad	Gujarat
India	Mavens'Hospital Ground Floor N 37, Opp Reliance Fresh, Vaishali Nagar	Ajmer	Rajasthan
India	BGS Global institute of Medical Sciences	Bangalore	Karnataka
India	KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi	Belgaum	Karnataka
India	Shettys Hospital	Bengaluru	Karnataka
India	Sri Lakshmi Superspeciality Hospital	Bengaluru	Karnataka
India	Sri Venkateshwara Hospitals, SKY HEIGHTS,Site#1/2,Sarjapura-Attibele, Main rd,Indelebele Village	Bengaluru	Karnataka
India	Saveetha Medical College and hospital	Chennai	Tamil Nadu
India	Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research Site	Chennai	Tamilnadu
India	BAJ RR Hosp and Res Cntr	Dombivli	Maharashtra
India	Aakash Healthcare Private Limited	Dwarka	New Delhi
India	ESIC Medical College & Hospital	Faridabad	Haryana
India	Sarvodaya Hospital and Research Centre	Faridabad	Haryana
India	St. Theresa's Hospital	Hyderabad	Andhra Pradesh
India	JNUIMSRC	Jaipur	Rajasthan
India	Tagore Hospital & Research Institute	Jaipur	Rajasthan
India	Department of Medicine	Kanpur	Uttar Pradesh
India	Calcutta School of Tropical Medicine	Kolkata	West Bengal
India	Ruby General Hospital Limited	Kolkata	West Bengal
India	Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte	Mangalore	Karnataka
India	Chopda Medicare & Research Centre Pvt. Ltd	Nashik	Maharashtra
India	Suyog Hospital, CR Dept, 2nd flr, B-wing	Nashik	Maharashtra
India	DEC-Health Care Hospital	Nellore	Andhra Pradesh
India	Vijaya Super Speciality Hospital	Nellore	Andhra Pradesh
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Indira Gandhi Inst of Medical Sciences	Patna	Bihar
India	Grant Medical Foundation	Pune	Maharashtra
India	J Govt Medical College & Sassoon, Gen Hospitals 1st Floor, ENT department, PGP Hall,Jai Prakash Narayan Road	Pune	Maharashtra
India	Lifepoint Multispecialty Hosp.	Pune	Maharashtra
India	HB Specialty Hosp. & Res Inst.	Rudrapur	Uttarakhand
India	Unity Hospital, Nr. D.R. World	Surat	Gujarat
India	Aman Hospital and Research Center	Vadodara	Gujarat
India	Rhythm Heart Institute - A Unit Of SLPL	Vadodara	Gujarat
India	King George Hospital	Visakhapatnam	Andhra Pradesh
Japan	Rinku General Medical Center	Izumisano-shi	Osaka-Fu
Japan	Kohokai Takagi Hospital	Okawa-shi	Fukuuoka-Ken
Japan	Kodaira Hospital	Toda-shi	Saitama-Ken
Japan	Tsuchiura Beryl Clinic	Tsuchiura-shi	Ibaraki-Ken
Japan	University of Tsukuba Hospital	Tsuchiura-shi	Ibaraki-Ken
Japan	Tashiro Endocrinology Clinic	Tsukuba-shi	Ibaraki-Ken
Kenya	Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer Centre	Eldoret
Malawi	Johns Hopkins Research Project, Queen Elizabeth Central Hospital	Chipatala Avenue	Blantyre
Malawi	Mangochi PHNG Study Site, Kamuzu University of Health Sciences, Private Bag 360, Room 805	Mangochi
Mexico	Centro de Inv. Médica Aguascalientes, (CIMA) Av. Independencia 2130, Int. A. Trojes de Alonso	Aguascalientes
Mexico	Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas	Aguascalientes
Mexico	Centro Inv. y Avances Med Especializados, (CIAME) Av. Kabah, Lote 38, 39 y 41., Manzana 4, supermanzana 44. Col., Alborada, Benito Juárez	Cancún	Q. Roo
Mexico	CAIMED Investigación en Salud,, S.A. de C.V., Manzanillo #100. Piso 2. Roma Sur	Cuauhtémoc	Cdmx,c.p
Mexico	Avenida Universidad 1001, Edificio 19, planta baja, colonia Chamilpa	Cuernavaca	Morelos
Mexico	Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.	Oaxaca de Juárez	Oaxaca
Mexico	FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165	Ricardo Flores Magón	Veracruz
Mexico	Instituto Veracruzano, en Investigación Clínica S.C., Sabino s/n, Colonia Reserva Tarimoya ll	Veracruz	CP
Pakistan	Rehman Medical Institute Clinical Trial Unit	Hayatabad	Peshawar
Pakistan	Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8	Islamabad
Pakistan	Dow Univ of Health Sciences Ojha Campus	Karachi
Pakistan	Sindh Infectious Disease Hospital and research Centre	Karachi
Pakistan	The Aga Khan University	Karachi	Sindh
Pakistan	Indus Hospital and Health Network	Korangi	Karachi
Pakistan	Akram Medical Complex	Lahore	Punjab
Pakistan	Central Park Teaching Hospital	Lahore	Punjab
Pakistan	National Hospital & Medical Center	Lahore	Punjab
Pakistan	Maroof International Hospital	Peshawar
Philippines	Healthlink Iloilo, Inc., No. 12, Mabini Str.	Iloilo City
Philippines	Ilocos Training and Regional Medical Center	La Union	San Fernando
Philippines	Mary Mediatrix Medical Cntr	Lipa	Batangas
Philippines	Iloilo Doctors' Hospital, Room 706, New Condoclinics Bldg, West Ave	Lloilo	Molo
Philippines	The Medical City Clark, #100Eatwick, Gatewick,Global Gateway Logistics City, Industrial Estate 5,Clark Freeport Zone	Mabalacat	Pampanga
Philippines	Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd	Mandaluyong
Philippines	Green City Medical Center	Pampanga	San Fernando
Philippines	Lung Center of the Philippines	Quezon City
Philippines	Mary Johnston Hospital, 1221 Juan Nolasco Street	Tondo	Manila
Poland	Ostrowieckie Centrum Medyczne	Ostrowiec Swietokrzyski
Poland	Medicome sp. z o.o.	Oswiecim
Poland	Centrum Medyczne "Medyk"	Rzeszów
Poland	Clinmedica Research sp. z o.o.	Skierniewice
Poland	Centrum Badan Klinicznych	Wroclaw
South Africa	JOSHA Research	Bloemfontein	Free State
South Africa	Task Eden Research Centre	George	Western Cape
South Africa	Newton Clinical Research Centre	Johanesburg	Gauteng
South Africa	(PHRU), New Nurses Home 9th floor Chris	Johannesburg	Gauteng
South Africa	CHRU, Themba Lethu Clinic	Johannesburg	Gauteng
South Africa	Worthwhile Clinical Trials	Johannesburg	Gauteng
South Africa	Ubuntu Clinical Research	Krugersdorp	Gauteng
South Africa	Ubuntu Clinical Research	Lenasia	Gauteng
South Africa	T/A Midrand Medical Centre, Shop #1, Health Emporium	Midrand	Gauteng
South Africa	Be Part Research PTY (LTD)	Paarl	Western Cape
South Africa	Global Clinical Trials	Pretoria	Gauteng
South Africa	Right to Care Research Esizayo, Right Clinic Esizayo	Randburg	Gauteng
South Africa	Roodepoort Medicross Clinical Research Centre	Roodepoort
South Africa	The Arum Institute NPC Rustenburg CRS	Rustenburg	North West
South Africa	Limpopo Clin Res Inititative Tamboti Medical Centre	Thabazimbi	Limpopo
Thailand	Siriraj Hospital	Bangkok Noi	Bangkok
Thailand	Research Institute for Health Sciences	Mueang Chiang Mai District	Chiang Mai
Thailand	Srinagarind Hospital	Mueang Khon Kaen District	Khon Kaen
Thailand	Thai Red Cross AIDS Research Centre	Pathum Wan	Bangkok
Turkey	Hacettepe Universitesi Tip Fakultesi, Hacettepe Universitesi Tip Fakultesi	Altindag	Ankara
Turkey	Acibadem Atakent Hospital	Kucukcekmece	Instanbul
Turkey	Dicle University Medical Faculty, Infectious Diseases Hospital Floor:5, Clinical Research Room	Sur	Diyarbakir
Uganda	Infectious Diseases Institute (IDI), Mulago Hill Road	Kampala
Uganda	Joint Clinical Research Centre	Kampala
Uganda	SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062	Lira
Uganda	IDRC Clinic, Tororo General Hospital, P.o.box 2, Station Rd	Tororo
United States	Renal Medicine Associates	Albuquerque	New Mexico
United States	Masters of Clinical Research	Augusta	Georgia
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Central Texas Medical Research	Austin	Texas
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Progressive Clinical Research	Bountiful	Utah
United States	Hope Clinical Research	Canoga Park	California
United States	UNC Global Infectious Diseases	Chapel Hill	North Carolina
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Rush University Infectious Diseases	Chicago	Illinois
United States	WellNow Urgent Care and Research	Cincinnati	Ohio
United States	Ohio State University College of Medicine	Columbus	Ohio
United States	Carbon Health	Culver City	California
United States	Care United Research, 375 North FM 548, suite 100	Forney	Texas
United States	Valley Institute of Research	Fort Worth	Texas
United States	Infusion Associates	Grand Rapids	Michigan
United States	Lakeview Clinical Research	Guntersville	Alabama
United States	Accurate Clinical Management, LLC	Houston	Texas
United States	AB Clinical Trials	Las Vegas	Nevada
United States	Ark Clinical Research (PARENT)	Long Beach	California
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Miami Clinical Research	Miami	Florida
United States	Vista Health Research, LLC	Miami	Florida
United States	Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208	Miami Beach	Florida
United States	Burke Primary Care	Morgantown	North Carolina
United States	Vanderbilt Health-One Hundred Oaks	Nashville	Tennessee
United States	Columbia University Irving Medical Center Division of Infectious Diseases	New York	New York
United States	NY Blood Center Project ACHIEVE	New York	New York
United States	Combined Research Orlando Phase I-IV	Orlando	Florida
United States	Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard	Ormond Beach	Florida
United States	Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	UPMC Eye Center - Eye and Ear Institute	Pittsburgh	Pennsylvania
United States	Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305	Pompano Beach	Florida
United States	Invictus Clinical Research Group, LLC	Pompano Beach	Florida
United States	Clinical Research Partners LLC	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Sun Research Institute, LLC	San Antonio	Texas
United States	UCSD Antiviral Research Center	San Diego	California
United States	University of California San Francisco (PARENT)	San Francisco	California
United States	Santos Research Center, CORP	Tampa	Florida
United States	Voyage Medical Services	Tempe	Arizona
United States	Clinical Trials Management Services, 223 E. Thousand Oaks Blvd.	Thousand Oaks	California
United States	Lundquist Institute for BMI, UCLA Medical Center	Torrance	California
United States	Novak Clinical Research	Tucson	Arizona
United States	Whitman-Walker Health	Washington	District of Columbia
United States	Progressive Medicine of the Triad, LLC	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Shionogi	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Colombia,  Ghana,  India,  Japan,  Kenya,  Malawi,  Mexico,  Pakistan,  Philippines,  Poland,  South Africa,  Thailand,  Turkey,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Time to Sustained Symptom Resolution		Up to Day 29
Secondary	Change From Baseline in Quantitative log10 SARS-CoV-2 RNA Levels by Polymerase Chain Reaction (PCR) on Nasopharyngeal (NP) Swab at Day 4		Baseline, Day 4
Secondary	Percentage of Participants With Adjudicated Hospitalization Due to COVID-19 or Death Due to Any Cause		Up to Day 29
Secondary	Percentage of Participants With Detectable SARS-CoV-2 by Viral Culture on NP Swab at Day 4		Day 4
Secondary	Percentage of Participants With Hospitalization (All Cause) or Death Due to Any Cause		Up to Day 29
Secondary	Percentage of Participants With Detectable SARS-CoV-2 by Viral Culture on NP Swab at Day 8		Day 8
Secondary	Percentage of Participants With NP SARS-CoV-2 RNA Levels by Quantitative PCR Below the Lower Limit of Quantification on Days 4 and 8		Days 4 and 8
Secondary	Median Change From Baseline of SARS-CoV-2 RNA by Quantitative PCR in NP Swabs on Day 8		Baseline, Day 8
Secondary	Median Time to Self-Reported Return to Usual (Pre-COVID-19) Health		Up to Day 29
Secondary	Percentage of Participants Reaching a Score =2, =3, =4, =5, =6, =7, or =8 on the Ordinal Scale		Up to Day 29
Secondary	Change From Baseline in Resting Peripheral Oxygen Saturation at Day 29		Baseline, Day 29
Secondary	Percentage of Participants With Resting Peripheral Oxygen Saturation =96%		Up to Day 29
Secondary	Percentage of Participants Exhibiting Persistent Symptoms and Clinical Sequelae		Up to Week 24
Secondary	Percentage of Participants With Symptomatic Viral Rebound as an Increase in Quantitative NP SARS-CoV-2 Viral Culture or NP SARS-CoV-2 RNA Levels by Quantitative PCR After Day 4 up to Day 29		Day 4 up to Day 29
Secondary	Percentage of Participants With Viral Rebound as an Increase in Quantitative NP SARS-CoV-2 Viral Culture or NP SARS-CoV-2 RNA Levels by Quantitative PCR After Day 4 up to Day 29		Day 4 up to Day 29
Secondary	Number of Participants With Adverse Events		Up to Week 24
Secondary	Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Quality of Life Score		Baseline, Week 24
Secondary	Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score		Baseline, Week 24
Secondary	Change From Baseline in Post-Acute COVID-19 Questionnaire		Baseline, Week 24
Secondary	Percentage of Participants Who Experienced Death Due to Any Cause		Up to Week 24