NCT04528927

Brief Summary

Evaluation of the efficacy and safety of Treatments for Patients Hospitalized for COVID-19 Infection without signs of acute respiratory failure, in Tunisia Multicentric Randomized Comparative Study

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

May 6, 2020

Last Update Submit

August 26, 2020

Conditions

COVID 19Patients Hospitalized

Outcome Measures

Primary Outcomes (2)

  • Evaluate the rate of patients cured at the end of the study.

    The healing criteria are defined clinically as: disappearance of clinical signs of acute respiratory infection absence of fever

    2 months

  • Evaluate the rate of patients are pauci-symptomatic at the end of the study.

    A patient will be defined as pauci-symptomatic if presence: * Light dry cough * Discomfort, * More or less : * Headache, * Muscle pain

    2 months

Secondary Outcomes (1)

  • Evaluate the rate of patients with worsening clinical signs

    2 months

Study Arms (3)

HCQ+Azithromycin

EXPERIMENTAL

* Hydroxychloroquine (HCQ): 600 mg on the 1st day as a starting dose then 200 mg \* 2 / D for 9 days * Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Usual standard treatment

Drug: HCQDrug: Azithromycin

HCQ+Azithromycin+Zinc

EXPERIMENTAL

* HCQ: 600 mg on the 1st day as a starting dose then 200 mg \* 2 / D for 9 days * Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Zinc: 220 mg per day for 10 days * Usual standard treatment

Drug: HCQDrug: AzithromycinDietary Supplement: Zinc

Azithromycin+Doxycycline

EXPERIMENTAL

* Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Doxycycline: 200 mg per day for 10 days. * Usual standard treatment

Drug: AzithromycinDrug: Doxycycline

Interventions

HCQDRUG

600 mg on the 1st day as a starting dose then 200 mg \* 2 /D for 9 days

HCQ+AzithromycinHCQ+Azithromycin+Zinc
AzithromycinDRUG

500 mg (1st day) then 250 mg / D for 4 days

Azithromycin+DoxycyclineHCQ+AzithromycinHCQ+Azithromycin+Zinc
DoxycyclineDRUG

200 mg per day for 10 days

Azithromycin+Doxycycline
ZincDIETARY_SUPPLEMENT

220 mg per day for 10 days

HCQ+Azithromycin+Zinc

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed patient COVID19 positive with clinical signs of acute lower respiratory infection with signs of pneumonia or bronchitis: fever and / or cough and / or difficulty breathing in the absence of acute respiratory failure (PaO2\> 60 mmHg) with Plus or less :
  • Chills
  • Asthenia, fatigability
  • Headache
  • Arthromas myalgia
  • Dry throat
  • Rhinorrhea
  • An anosmia
  • chest pain
  • Diarrhea
  • Nausea and vomiting
  • Absence of rhythm disturbance (Qt interval \<500ms)
  • Patients hospitalized in the medical service
  • years old \<Age \<80 years old
  • Having given written consent for their participation in the study

You may not qualify if:

  • Allergy to macrolides, local anesthetics such as lidocaine or amide type and betalactamines
  • Take hydroxychloquine in the previous month
  • Severe / severe liver failure
  • Kidney failure (GFR \<30 ml / min / 1.73 m2)
  • Ongoing treatments with colchicine, ergot, rye, pimozide, mizolastine, simvastatin, lomitapide, alfuzosin, dapoxetine, avanafil, ivabradine, eplerenone, dronedarone, quetiapine, ticagrelor, cisapride, astemizole, terfenadine, ranolazine, domperidone.
  • Complete branch block
  • Hypovolemia
  • Retinopathy including vitreous involvement
  • Psoriasis
  • Pregnant or breastfeeding woman
  • hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients of this medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eshmoun Clinical Research Centre

Tunis, 1053, Tunisia

Location

MeSH Terms

Conditions

COVID-19

Interventions

AzithromycinDoxycyclineZinc

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

May 6, 2020

First Posted

August 27, 2020

Study Start

May 15, 2020

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

August 27, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)