PROTECT: Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)

Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04363827
Collaborator
University of Bologna (Other)
2,300
1
4
15.6
147.4

Study Details

Study Description

Brief Summary

This is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early phase COVID-19 population (Group 2).

The participants will be randomised to receive either:

Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is an open label, superiority, cluster-randomized Italian interventional clinical trial, evaluating the role of Hydroxychloroquine versus observation only in preventing infection to COVID-19 or treating early phase COVID-19 patients.

Each index case is randomised to either Arm A: Hydroxychloroquine or Arm B: observation in a 2:1 ratio on an open label basis. Participants in the same cluster receive the same intervention.

Study population is constituted by:

Group 1: Severe Acute Respiratory Syndrome (SARS) - Corona Virus (CoV)-2-exposed subjects , as household members/contacts of COVID-19 patients.

Group 2: Patients with COVID-19 asymptomatic or paucisymptomatic in home situation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)
Actual Study Start Date :
May 14, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: Hydroxychloroquine

A loading dose Hydroxychloroquine 400 mg twice daily at day 1, followed by a weekly dose of Hydroxychloroquine 200 mg twice daily on days 8, 15 and 22, covering a total of 1 month of treatment.

Drug: Hydroxychloroquine
Hydroxychloroquine

No Intervention: Group 1: Observation

observation only

Experimental: Group 2: Hydroxycloroquine

A loading dose Hydroxychloroquine 400 mg twice daily at day 1 followed by 200 mg twice daily for a total of at least 5-7 days according to clinical evolution.

Drug: Hydroxychloroquine
Hydroxychloroquine

No Intervention: Group 2: Observation

Observation only

Outcome Measures

Primary Outcome Measures

  1. the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization. [within 1 month from randomization]

    Group 1:The primary endpoint/outcome measure is the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.

  2. the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization. [within 14 days from randomization]

    Group 2: The primary endpoint/outcome measure is the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

Secondary Outcome Measures

  1. The proportion of subjects with positive swabs in Group 1 within 1 month from randomization in both arms [within 1 month from randomization]

    The proportion of subjects with positive swabs in randomized population of SARS-CoV-2-exposed subjects ( Group 1) within 1 month from randomization in both arms

  2. The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization [within 1 month from randomization]

    The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization, in subgroup population identified by stratification factors, class of age and gender.

  3. The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization. [within 14 days from randomization]

    The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization, in subgroup population identified by stratification factors, class of age and gender.

  4. The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population [within 1 month from randomization]

    The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population identified by stratification factors, class of age and gender.

  5. Absolute and relative frequencies of Serious Adverse Events [up to 10 months]

    Absolute and relative frequencies of Serious Adverse Events (CTCAE version 5.0) in both arms for the Group 1 and Group 2.

  6. Variation in Quality of Life scores in different time points [up to 10 months]

    Variation in Quality of Life scores EQ-5D-5L (EQ-5D descriptive system with 5 severity levels from better to worse, and the EQ visual analogue scale (EQ VAS, scale from 100 to 0, high is better) in different time points (weekly) respect to baseline values in both Group 1 and Group 2 populations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Male or Female, aged >= 18 years

  2. SARS-CoV-2-exposed subjects, as household members and/or contacts of COVID-19 patients (Group 1). In this group are included Health care professionals in contact with COVID-19 patients.

or

  1. COVID-19 patients, asymptomatic or paucisymptomatic in home situation who are not in treatment with any anti COVID-19 medication (Group 2)

  2. Absence of any COVID-19 symptom in last week before randomization (fever >37.5°C, cough, dyspnea) (only for group 1 subjects)

  3. Paracetamol treatment is accepted only for group 2.

  4. Participant is willing and able to give informed consent for participation in the study (either recorded during a telephonic interview or signed in person) and agrees with the study and its conduct.

Exclusion Criteria:
  1. Reported anamnesis for:

  2. Intolerance or previous toxicity for hydroxychloroquine/chloroquine

  3. Bradycardia or reduction rhythm of heart with arrythmias

  4. Ischemic heart disease

  5. Retinopathy

  6. Congestive heart failure under/with use of diuretics

  7. Favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency

  8. Diabetes type 1

  9. Major comorbidities like advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmias, any oncologic/hematologic malignancy.

  10. Severe neurological and mental illness

  11. Any other contraindication to take hydroxychloroquine

  12. Already taking chloroquine, hydroxychloroquine or analogous during the past 3 weeks

  13. Use of other antiviral agents in the last 3 weeks

  14. Subject with a positive test for SARS-CoV-2 (for Group 1)

  15. Pregnant or lactating

  16. Current use of medications with known significant drug-drug interactions: digoxin, hypoglycemic agents, anticonvulsant, Cyclosporine, Phenylbutazone, drugs that inhibit CYP2D6

  17. Known prolonged QT syndrome or current use of drugs with known QT prolongation

  18. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Irst Irccs Meldola FC Italy 47014

Sponsors and Collaborators

  • Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
  • University of Bologna

Investigators

  • Study Chair: Giovanni Martinelli, Prof., Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS , Meldola Italy
  • Study Chair: Pierluigi Viale, Prof., Univeristy of Bologna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier:
NCT04363827
Other Study ID Numbers:
  • IRST100.47
First Posted:
Apr 27, 2020
Last Update Posted:
Feb 12, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 12, 2021