Trial of Hydroxychloroquine In Covid-19 Kinetics

NCT04353271 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: [1582736-1]
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

To test if the medication Hydroxychloroquine will decrease the amount of virus(as measured by PCR) , 7 days after initiation of therapy compared to control patients receiving placebo. The study design is a randomized (5 days of medication v. 5 days of placebo) clinical trial initiated immediately after diagnosis in ambulatory health care workers at University of South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical trial.

Conditions

Covid 19; Corona Virus Infection

Keywords

covid 19; plaquenil; hydroxychloroquine

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Are Virus Free

  Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs

  7 days after initiation of trial

• Disease Severity

  Participants will self-report disease severity status as one of the following 5 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization (score of 3), or Covid 19 with care requiring hospitalization (score of 4), or Covid 19 with death (Score of 5) .

  6 days

Secondary Outcomes (5)

• Number of Participants Who Are Hospitalized for Covid 19 Infection

  14 days

• Number of Participants Who Die Secondary to Covid 19 Infection

  70 Days (10 weeks)

• Number of Participants Who Have Confirmed Covid 19 Infection

  14 days

• Number of Participants Who Discontinue or Withdraw Medication Use for Any Reason

  14 days

• Immunity to Covid-19

  70 days (10 weeks)

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

Subjects in this arm will receive the study drug

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Subjects in this arm will take placebo for 6 days

Other: Placebo

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days.

Also known as: plaquenil

Hydroxychloroquine

Placebo OTHER

Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.

Placebo

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms occurring within 3 days prior to patient presenting to USA Facility for PCR nasopharyngeal swab
• Nasopharyngeal swab positive for Covid-19 infection and/or exposure and/or symptoms congruent with fever and cough
• Male or Female age 19 to 89 years
• Able to take oral medications
• Patients not requiring hospitalization
• Provision of informed consent

You may not qualify if:

• Known history of EKG QTc prolongation abnormality
• Contraindication or allergy to hydroxychloroquine
• Retinal eye disease
• Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
• Known chronic kidney disease, stage 4 or 5 or receiving dialysis
• Weight \< 40 kg
• Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal)
• Known hepatic disease (cirrhosis, hepatitis)
• Active treatment for cancer (chemotherapy, radiation, surgery within 3 months
• On immunosuppressive drugs steroids, antirejection medications.
• Recipient of solid organ transplant
• Pregnancy/breastfeeding
• Past medical history Porphyria (may exacerbate disease)
• PMH Psoariasis (can worsen disease)
• No access to internet or email

Sponsors & Collaborators

• University of South Alabama: lead

Study Sites (1)

University of South Alabama

Mobile, Alabama, 36604, United States

Location

Related Publications (29)

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MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Office of Research Complaince
• Organization: University of South Alabama

swhite@southalabama.edu

2514607573

Study Officials

• William O Richards, MD

  University of South Alabama College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded to subject and investigators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Surgery

Model Details: Randomized placebo verses medication clinical trial

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 20, 2020
• Study Start: April 17, 2020
• Primary Completion: July 8, 2020
• Study Completion: July 8, 2020
• Last Updated: January 3, 2022
• Results First Posted: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)