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Antimalarial

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

Phase 2
Waitlist Available
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
Must not have
Type I or II diabetes
Any contraindication for treatment with hydroxychloroquine including: Hypoglycemia, G6PD deficiency, Porphyria, Anemia, Neutropenia, Alcoholism, Myasthenia Gravis, Skeletal muscle disorder, Maculopathy, Changes in the visual field, Liver disease, with ALT/AST > 2.5 upper limit normal and total bilirubin >2.5 upper limit normal, Psoriasis, Any contraindicated medications found in Appendix 2, Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject, Vaccination for SARS-CoV-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Type I or II diabetes.
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I do not have health conditions that react badly to hydroxychloroquine.
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I am showing symptoms of COVID-19.
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I have been diagnosed with heart artery blockage.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Wolff-Parkinson-White syndrome
1%
Coronary artery occlusion
1%
Anaemia
1%
Leukopenia
1%
Lumbar spinal stenosis
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
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)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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
~3670
Vitamin C
2017
Completed Phase 4
~18470
Zinc
2005
Completed Phase 4
~16490
Hydroxychloroquine
FDA approved

Find a Location

Who is running the clinical trial?

ProgenaBiomeLead Sponsor
45 Previous Clinical Trials
4,750 Total Patients Enrolled
DSCS CROIndustry Sponsor
2 Previous Clinical Trials
136 Total Patients Enrolled
Sabine Hazan, MDPrincipal InvestigatorProgenaBiome
40 Previous Clinical Trials
4,429 Total Patients Enrolled

Media Library

Hydroxychloroquine (Antimalarial) Clinical Trial Eligibility Overview. Trial Name: NCT04335084 — Phase 2
Coronavirus Research Study Groups: Medical Workers, Placebo
Coronavirus 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
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