NCT05004753

Brief Summary

This will be an open label, prospective, multi-center, comparative, interventional study to evaluate safety and efficacy of Artemisinin 500 mg in subjects with mild to moderate COVID-19. Initially subjects having mild to moderate COVID-19 will be screened as per predefined eligibility criteria for the study. Eligible 120 subjects will be enrolled to receive treatment with Artemisinin and SOC (Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)) or SOC. Subjects will be randomized in 2:1 ratio. Group 1 will have 80 subjects and Group 2 will have 40 subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_4 covid19

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
Last Updated

September 9, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

July 26, 2021

Last Update Submit

September 1, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Safety Assessments

    * Incidence of adverse events during the study. * Incidence of serious adverse events during the study.

    28 days

Secondary Outcomes (1)

  • Efficacy Assessments

    28 days

Study Arms (2)

Artemisinin 500mg

EXPERIMENTAL

The dose regimen will be in cycles. In a cycle a subject will receive Artemisinin 500 mg capsule once daily plus SOC on Day 1 to Day 5 followed by 5 days off (no dosing of Artemisinin) or SOC alone. A subject can have a total of consecutive 3 cycles maximum. Here SOC is Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)

Dietary Supplement: Artemisinin

Standard of Care

ACTIVE COMPARATOR

Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division) Mild Patients: HYDROXYCHLOROQUINE Moderate Patients: Dexamethasone - OD for 05

Drug: Dexamethasone

Interventions

ArtemisininDIETARY_SUPPLEMENT

a herbal supplement

Artemisinin 500mg
DexamethasoneDRUG

corticosteroids

Standard of Care

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female subjects of ≥18 to 60 years of age both inclusive
  • Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  • Confirmed case of COVID-19 infection by RT-PCR and mild and moderate (without oxygen therapy or assisted ventilation) cases of COVID-19. Scores of 2-4 on the WHO Clinical Progression Scale
  • Time interval between symptoms onset and randomization of no more than 7 days
  • One or more of the following symptoms:
  • Fever Cough Sore throat Headache Nasal congestion Malaise Diarrhea Loss of smell Loss of taste
  • Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.

You may not qualify if:

  • Subjects with history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening
  • Known or suspected hypersensitivity to Artemisinin
  • Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
  • Men who are unwilling to use contraception while receiving investigational product
  • Subjects with history of severe disease other than COVID-19 which is expected to prevent compliance with the present protocol
  • Subjects with history of severe renal and hepatic impairment. (creatine ≥2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN)
  • Recent treatment with Artemisinin or Artemisinin based antimalarials in the past 7 days
  • Known history of failure to control systemic fungal, bacterial or viral infection
  • Patients with the history of following co-morbidities: diabetes, hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome
  • Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection
  • Have a history of neurological or psychiatric disorders, including epilepsy or dementia
  • Subjects for whom ventilator support is required at screening
  • Patients not willing to stay in hospital for 5 days of isolation following diagnosis of Covid-19
  • Subjects not willing to give their informed consent to participate in the clinical trial
  • According to the investigator judgment there are concomitant diseases with a serious safety hazard or affect the subject
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Government Medical College & Government General Hospital, Srikakulam

Srikakulam, Andhra Pradesh, 532001, India

Location

Rajarshi Chhatrapati Shahu Maharaj Government Medical college and Chhatrapati Pramila Raje Hospital

Kolhāpur, Maharashtra, 431001, India

Location

Seven Star Hospital

Nagpur, Maharashtra, 440009, India

Location

Related Publications (1)

  • Trieu V, Saund S, Rahate PV, Barge VB, Nalk KS, Windlass H, Uckun FM. Targeting TGF-beta pathway with COVID-19 Drug Candidate ARTIVeda/PulmoHeal Accelerates Recovery from Mild-Moderate COVID-19. Clinical Investigation (2021) 11(1), 10-18

    RESULT

MeSH Terms

Conditions

COVID-19

Interventions

artemisininDexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Mukesh Kumar

    Windlas Biotech Private Limited

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 to 1 ratio
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 13, 2021

Study Start

September 30, 2020

Primary Completion

February 28, 2021

Study Completion

April 30, 2021

Last Updated

September 9, 2021

Record last verified: 2021-08

Locations

IN(3)