Trial no.:	PACTR202210559228718	Date of Approval:	12/10/2022
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

A Study of JT001 (VV116) for the Early Treatment of Mild to Moderate COVID-19

Official scientific title

A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of JT001 (VV116) for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Participants with Mild to Moderate COVID-19

Brief summary describing the background and objectives of the trial

JT001 (VV116) is intended for the treatment of novel coronavirus pneumonia (COVID-19). JT001 (VV116) is a prodrug that is metabolized into the nucleoside form (116-N1, VV116-3) in the body, and 116-N1 further forms the nucleoside triphosphate active form intracellularly to inhibit the RNA-dependent RNA polymerase of SARS-CoV-2 and thus exert antiviral effects Primary Objectives: Characterize the effect of JT001 (VV116) compared to placebo on overall participant clinical status Secondary Objectives: The secondary objectives are to characterize the effect and safety of JT001 (VV116) compared to placebo on Overall participant clinical status, COVID-19-related hospitalization rate of non-hospitalized participants,SARS-CoV-2 negative rate through Day7#, The plasma concentration of JT001 (VV116) and major metabolites when administered orally to participants (optional) and Safety

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Respiratory

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Drugs

Anticipated trial start date

31/10/2022

Actual trial start date

Anticipated date of last follow up

31/10/2023

Actual Last follow-up date

Anticipated target sample size (number of participants)

1310

Actual target sample size (number of participants)

Recruitment status

Not yet recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Permuted block randomization	Central randomisation by phone/fax	Masking/blinding used	Care giver/Provider,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	JT001 drug	First day: JT001 (VV116) 600mg Q12H X 2 times Day 2-5: JT001 (VV116) 300mg Q12H X 8 times	5 days	JT001 is a prodrug that is metabolized into the nucleoside form (116-N1, VV116-3) in the body, and 116-N1 further forms the nucleoside triphosphate active form intracellularly to inhibit the RNA-dependent RNA polymerase of SARS-CoV-2 and thus exert antiviral effects.	655
Control Group	Placebo	First day: 6 tablets Q12H X 2 times Day 2-5: 3 tablets Q12H X 8 times	5 days	Placebo	655	Placebo

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Participants of 18 years of age or older, at the time of signing of informed consent Participants who have a positive SARS-CoV-2 test result, and have sample collection for first positive SARS-CoV-2 viral infection determination ≤5 days prior to randomization Participants who have one or more mild or moderate COVID-19 symptoms as follows and have a COVID-19 Related Symptom score ≥3  fever  cough  sore throat  stuffy or running nose,  headache  muscle pain  shortness of breath or difficulty breathing  nausea Chills or shivering  vomiting  diarrhea Participants with the onset of symptoms of COVID-19 ≤5 days prior to randomization Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death:  Are ≥ 60 years of age  Cardiovascular disease (including congenital heart disease and hypertension)  Chronic lung diseases (for example, chronic obstructive pulmonary disease (COPD), asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension)  Diabetes  Immunosuppressive disease or immunosuppressive treatment(for example，long-term use of corticosteroids or other immunosuppressive drugs lead to decreased immune function)  Overweight or obesity BMI>25 kg/m2  Sickle cell disease  Active cancer  Chronic kidney disease  Current smoker  Neurodevelopmental disorders (e.g., cerebral palsy, Down’s syndrome) or other conditions that confer medical complexity (e.g., genetic or metabolicsyndromes and severe congenital anomalies)  Need relevant medical support (not related to COVID-19) (such as tracheotomy, gastrostomy or positive pressure ventilation, etc.) Participants who must agree to adhere to contraception restrictions Participants who understand and agree to comply with planned study procedures Participants can give written informed consent approved by the Ethical Review Board governing the site and comply with the requirements and restrictions l	Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization. Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300(with oxygen inhalation), or respiratory rate ≥30 per minute, or heart rate ≥125 per minute Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation Participants who are suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention Participants who have eye disease (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion) Participants who have ALT or AST>2 ULN at screening Participants who have known allergies to any of the components used in the formulation of the interventions Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within180 days prior to screening visit Participants who have received convalescent COVID-19 plasma treatment within180 days prior to screening visit Participants who have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study Female who is pregnant or breast-feeding or plan to be pregnant within this study period	80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	80 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

No

09/09/2022

National Health Research Ethics Committee Nigeria

Ethics Committee Address
Street address	City	Postal code	Country
PMB 083	Abuja	900241.	Nigeria

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Characterize the effect of JT001 (VV116) compared to placebo on overall participant clinical status	through Day 28
Secondary Outcome	Characterize the effect of JT001 (VV116) compared to placebo on COVID-19-related hospitalization rate of non-hospitalized participants	By day 28
Secondary Outcome	Characterize the effect of JT001 (VV116) compared to placebo on SARS-CoV-2 negative rate	Through day 5 7
Secondary Outcome	Characterize the effect of JT001 (VV116) compared to placebo on the plasma concentration of JT001 (VV116) and major metabolites when administered orally to participants (optional)	Through day 28
Secondary Outcome	Characterize the effect of JT001 (VV116) compared to placebo on safety	Through day 28

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
University of Calabar Teaching Hospital	PMB 1278 Cross River State	Calabar		Nigeria

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Shanghai JunTop Biosciences Co Ltd and Vigonvita Life Sciences Co Ltd	15th Floor, Building 7, No.6 Lane 100 PingJiaQiao Road, Pudong New Area	Shanghai		China

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Shanghai JunTop Biosciences Co LTD	15th Floor, Building 7, No.6 Lane 100 PingJiaQiao Road, Pudong New Area	Shanghai		China	Commercial Sector/Industry

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Udoh Ubong	ubong4dr@yahoo.com	+257123456	PMB 1278, Cross River State
City	Postal code	Country	Position/Affiliation
Calabar		Nigeria	PI
Role	Name	Email	Phone	Street address
Scientific Enquiries	Tong Liu	tong_liu1@junshipharma.com	8615021535284	No 100-6-7, Pingjiaqiao Rd, Pudong shanghai,China
City	Postal code	Country	Position/Affiliation
Shangai		China	Medical Manager
Role	Name	Email	Phone	Street address
Public Enquiries	Michelle Botha	michelle.botha@quintiles.com	+27828888132	BCX Campus, 1021
City	Postal code	Country	Position/Affiliation
Centurion		South Africa	Associate Director

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Currently there are no plans of sharing IPD	Clinical Study Report	N/A	N/A
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry