Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chemoprevention Clinical Trial of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis (APCC-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04597775
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Farhat Hached Hospital, Tunisia
Fattouma Bourguiba, Tunisia
Information provided by (Responsible Party):
Dr Munir Abu-Helalah, Regional Center for Disease Control and Prevention, Jordan

Brief Summary:

Protocol summary

Title

A Prospective, randomized, adaptive phase II/III clinical trial, controlled, open-label, chemoprevention, 3-arms, parallel, multi-centred, to A Prospective, randomized, clinical trial, controlled, open-label, 3-arms, parallel, multi-centred, chemoprevention of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis For COVID-19

Study Periods & Duration of Treatment

Study Duration: 6 months

Approval (IRB and regulatory bodies) 1 month

Recruitment and follow-up: 3 months

Analysis, report writing and submission of publications 1 month This study is a parallel study of one period with an expected duration of treatment (for each subject) of 28 days,

Objectives

  • To evaluate if hydroxychloroquine with the proposed dose can provide potent chemoprophylaxis against the development of COVID-19 positive patients in subjects who had primary exposure to COVID-19 positive patients.
  • To measure the incidence of potential adverse drug reaction rates for giving hydroxychloroquine for prevention of COVID-19 amongst close contacts
  • To provide early analysis of results and redefine sample size accordingly.
  • identifying subjects most likely to benefit during the phase II and focusing recruitment efforts on them during phase III
  • stopping one arm or the whole trial at an early stage for success or lack of efficacy based on phase II study results

Design

Prospective, Randomized, open-label, three-arm, parallel, adaptive phase II/III controlled study in which subjects will be randomly assigned in a 1:1:1 ratio as per the following:

Arm-1: hydroxychloroquine 800mg (400mg twice daily) given orally on day 1, (loading dose) hydroxychloroquine. Then 400mg (200mg 2 tablets) on day 2,3, 4 and 5.

Arm-2: hydroxychloroquine 400mg (200mg twice daily) Given orally first day (loading dose), then 200mg once daily on day 2,3, 4 and 5.

Arm-3: No Intervention- SARS-CoV-2 surveillance Standard control measures in the country of interest such as self isolation, good personal hygiene and good nutrition.


Condition or disease Intervention/treatment Phase
SARS-CoV Infection Drug: hydroxychloroquine Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective, Randomized, open-label, three-arm, parallel, adaptive phase II/III controlled study in which subjects will be randomly assigned in a 1:1:1 ratio as per the following:

Arm-1: hydroxychloroquine 800mg (400mg twice daily) given orally on day 1, (loading dose) hydroxychloroquine. Then 400mg (200mg 2 tablets) on day 2,3, 4 and 5.

Arm-2: hydroxychloroquine 400mg (200mg twice daily) Given orally first day (loading dose), then 200mg once daily on day 2,3, 4 and 5.

Arm-3: No Intervention- SARS-CoV-2 surveillance Standard control measures in the country of interest such as self isolation, good personal hygiene and good nutrition.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Adaptive Phase II/III Clinical Trial, Controlled, Open-label, 3-arms, Parallel, Multi-centred, Chemoprevention of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis For COVID-19
Estimated Study Start Date : October 27, 2020
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 31, 2021


Arm Intervention/treatment
Experimental: Arm 1 hydroxychloroquine 800mg day 1 and hydroxychloroquine 400mg day 2-5
hydroxychloroquine 800mg (400mg twice daily) given orally on day 1, (loading dose) hydroxychloroquine. Then 400mg (200mg 2 tablets) on day 2,3, 4 and 5.
Drug: hydroxychloroquine
hydroxychloroquine
Other Name: plaquenil

Active Comparator: Arm 2 hydroxychloroquine 400mg day 1 and hydroxychloroquine 200mg day 2-5
hydroxychloroquine 400mg (200mg twice daily) Given orally first day (loading dose), then 200mg once daily on day 2,3, 4 and 5.
Drug: hydroxychloroquine
hydroxychloroquine
Other Name: plaquenil

No Intervention: No Intervention
No Intervention- SARS-CoV-2 surveillance Standard control measures in the country of interest such as self isolation, good personal hygiene and good nutrition.



Primary Outcome Measures :
  1. Incidence rate of COVID-19 on day 14 according to positive results of RT-PCR rate at day 14 [ Time Frame: 14 days ]
    Study will seek to find direct correlation between the administration of Hydroxychloroquine and incidence of COVID-19: A reduced positive RT-PCR samples in subjects who were exposed to COVID-19patients. Positive RT-PCR samples in close contacts on day 14 of randomization.

  2. Safety and adverse events (AEs) incidence rate at day 14 [ Time Frame: 14 days ]
    Safety and adverse events (AEs) incidence rate at day 14


Secondary Outcome Measures :
  1. IgM antibodies positive rate for COVID-19 at day 28 [ Time Frame: 28 days ]
    Positive IgM antibodies

  2. Incidence rate of COVID-19 on day 28 according to positive results of RT-PCR rate at day 28 [ Time Frame: 28 days ]
    Positive at 28 days

  3. Safety and adverse events (AEs) incidence rate on day 28 [ Time Frame: 28 days ]
    Safety and adverse events (AEs) incidence rate on day 28



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary contacts, described below, aged 18 to 65 years and having provide Written informed consent by the patient, by the patient's legal /authorized representative as applicable.

According to below criteria, as soon as a new subject in identified, he/she will be consented for reaching his contacts according to below criteria. The research team within 48 hours of index case identification will call his/her contacts who fulfill below criteria for participation in the trial. All potential participants will be tested using RT-PCR and IgM and IgG antibodies to rule out current or previous disease status.

Contact is a person free from COVID-19 who experienced any one of the following exposures during the 2 days before and the 14 days after the onset of symptoms of a probable or confirmed case:

  • A person living in the same household as a COVID-19 case
  • A person having had direct physical contact with a COVID-19 case (e.g. shaking hands)
  • A person having unprotected direct contact with infectious secretions of a COVID-19 case (e.g. being coughed on, touching used paper tissues with a bare hand)
  • A person having had face-to-face contact with a COVID-19 case within 2 meters [2] and > 15 minutes
  • A person who was in a closed environment (e.g. classroom, meeting room, hospital waiting room, etc.) with a COVID-19 case for 15 minutes or more and at a distance of less than 2 meters
  • A healthcare worker (HCW) or other person providing direct care for a COVID-19 case, or laboratory workers handling specimens from a COVID-19 case without recommended personal protective equipment or with a possible breach of personal protective equipment use policies
  • A contact in an aircraft sitting within two seats (in any direction) of the COVID-19 case, travel companions or persons providing care, and crew members serving in the section of the aircraft where the index case was seated (if severity of symptoms or movement of the case indicate more extensive exposure, passengers seated in the entire section or all passengers on the aircraft may be considered close contacts)

Exclusion Criteria:

  • Women who are pregnant (at the time of screening) or breastfeeding
  • known hypersensitivity or allergy to hydroxychloroquine or other aminoquinoline compounds
  • History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis
  • History of pre-existing retinopathy or maculopathy,
  • concomitant use of tamoxifen
  • History of congenital or acquired long QT-interval, current use of drugs that prolong the QT interval,
  • family history of long QT arrythmia, cardiac disease such as heart failure, myocardial infarction
  • concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death, or sudden cardiac death, bradycardia < 50 beats/min, uncorrected hypokalemia or hypomagnesemia
  • severe renal disease or patients receiving dialysis
  • Patients less than 35 kg bodyweight
  • Currently taking Hydroxychloroquine
  • Suspected or confirmed current COVID-19, defined as: (1) temperature > 38 Celsius; (2) cough; (3) shortness of breath; (4) sore throat; or, if available (not required), (5) positive confirmatory testing for COVID-19
  • Inability to take medications orally
  • Inability to provide written consent
  • With significantly abnormal liver function
  • Participants with psoriasis, myasthenia, hematopoietic and retinal diseases, CNS-related hearing loss;
  • RT-PCR positive for SARS-CoV-2, IgM and IgG antibodies for SARS-CoV-2
  • Currently using another treatment regimen or medication that is being investigated for efficacy in the management of COVID-19.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597775


Contacts
Layout table for location contacts
Contact: Munir A Abu-Helalah, PhD 00962795912413 ext 0 mabuhelalah@yahoo.co.uk
Contact: Amer A Amous, MD 00962797950001 ext 0 amer.amous@rcdcp.org

Sponsors and Collaborators
Regional Center for Disease Control and Prevention, Jordan
Farhat Hached Hospital, Tunisia
Fattouma Bourguiba, Tunisia
Investigators
Layout table for investigator information
Principal Investigator: Munir Abu-Helalah, PHD Regional Center for Disease Control
Study Chair: Wissem Hachfi, MD Farhat Hached Hospital, Tunisia
Layout table for additonal information
Responsible Party: Dr Munir Abu-Helalah, Chief Executive Officer, Regional Center for Disease Control and Prevention, Jordan
ClinicalTrials.gov Identifier: NCT04597775    
Other Study ID Numbers: APCC-19
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Through publications in Peer Review Journal

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr Munir Abu-Helalah, Regional Center for Disease Control and Prevention, Jordan:
COVID-19
SARS-CoV-2
Chemoprevention
Primary contact
Hydroxychloroquine
prophylaxis
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents