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Antimalarial

Combination Prevention Therapy for COVID-19 (HELPCOVID-19 Trial)

Phase 2

Recruiting

Led By Sabine Hazan, MD

Research Sponsored by ProgenaBiome

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

HELPCOVID-19 Trial Summary

This trial is testing whether a combination of hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19.

Who is the study for?

This trial is for adults over 18 who are at high risk of COVID-19 exposure, like healthcare workers. Participants must use two effective birth control methods if applicable and give informed consent. It's not for those with diabetes, previous COVID-19 infection, symptoms of the virus, certain heart diseases or conditions that hydroxychloroquine could worsen.Check my eligibility

What is being tested?

The study is testing if a combination of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent COVID-19 symptoms in people at high risk of exposure. This Phase II trial aims to see how effective these treatments are together.See study design

What are the potential side effects?

Potential side effects may include digestive issues due to vitamins and minerals; hydroxychloroquine might cause vision changes or muscle weakness among others. The exact side effects will be monitored throughout the study.

HELPCOVID-19 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prevention of COVID-19 symptoms as recorded in a daily diary

Safety as determined by presence or absence of Adverse Events and Serious Adverse Events

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250

13%

Upper respiratory tract infection

Neutropenia

Sinusitis

Alanine aminotransferase increased

Urinary tract infection

Injection site erythema

Accidental overdose

Bronchitis

Injection site pruritus

Thrombocytopenia

Nasopharyngitis

Contusion

Arthralgia

Anaemia

Lumbar spinal stenosis

Leukopenia

Coronary artery occlusion

Wolff-Parkinson-White syndrome

Transient ischaemic attack

Vertebrobasilar insufficiency

Chronic obstructive pulmonary disease

Small intestinal obstruction

Nephrolithiasis

Cataract

Thrombophlebitis superficial

Vomiting

Endometrial hyperplasia

Traumatic arthritis

Hypertension

Pneumonia

Pancreatic carcinoma metastatic

Osteoarthritis

Rheumatoid lung

Pharyngitis

Femoral neck fracture

100%

80%

60%

40%

20%

Study treatment Arm

Sarilumab 150 mg by PFS (Extension Phase)

Sarilumab 150 mg by AID (AID Assessment Phase)

Sarilumab 150 mg by PFS (AID Assessment Phase)

Sarilumab 200 mg by PFS (AID Assessment Phase)

Sarilumab 200 mg by AID (AID Assessment Phase)

HELPCOVID-19 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Medical WorkersExperimental Treatment4 Interventions

Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.

Group II: PlaceboPlacebo Group3 Interventions

Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin D

2013

Completed Phase 4

~3470

Vitamin C

2017

Completed Phase 4

~18470

Zinc

2005

Completed Phase 4

~17050

Hydroxychloroquine

FDA approved

Do I qualify?Apply below to find out

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Who is running the clinical trial?

ProgenaBiomeLead Sponsor

44 Previous Clinical Trials

4,730 Total Patients Enrolled

6 Trials studying COVID-19

699 Patients Enrolled for COVID-19

DSCS CROIndustry Sponsor

2 Previous Clinical Trials

136 Total Patients Enrolled

1 Trials studying COVID-19

118 Patients Enrolled for COVID-19

Sabine Hazan, MDPrincipal InvestigatorProgenaBiome

40 Previous Clinical Trials

4,429 Total Patients Enrolled

6 Trials studying COVID-19

699 Patients Enrolled for COVID-19

Media Library

Hydroxychloroquine (Antimalarial) Clinical Trial Eligibility Overview. Trial Name: NCT04335084 — Phase 2

COVID-19 Research Study Groups: Medical Workers, Placebo

COVID-19 Clinical Trial 2023: Hydroxychloroquine Highlights & Side Effects. Trial Name: NCT04335084 — Phase 2

Hydroxychloroquine (Antimalarial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04335084 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participants to join this experiment presently?

"Clinicaltrials.gov reports that this medical trial, which began recruiting on June 22nd 2020, is still actively seeking patients. The last update to the study was made in October of 2021."

Answered by AI

What is the current participant count in this clinical experiment?

"Affirmative. Clinicaltrials.gov has verified that this investigation, which was initially made available on June 22nd 2020, is in the process of recruiting volunteers. 600 participants must be gathered from 1 medical hub to successfully complete the trial."

Answered by AI