Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+)

Patients With COVID19 Clinical Trial

— COVID+PA  

Official title:

Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+), inTunisia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04351919
• Other study ID #: ECC2020-04
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 5, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: August 2020
• Source: Abderrahmane Mami Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess the number of patients who become asymptomatic from clinical signs of COVID19 and will assess the efficacy of Hydroxychloroquine (HCQ) and Azithromycine effects on paucisymptomatic patients with ou without co-morbidities

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• confirmed COVID19 (+)

• Qt<500ms

• no severity criteria

• pauci-symptomatique patients

• signed consent form

Exclusion Criteria:

• no confirmed patient COVID19

• severity criteria

• known allegies to macrolides and HCQ

• Treated with HCQ within 1 month prior to inclusion

• hepatitis insufficiency

• Renal insufficiency

• treatment no indicated with azithro and HCQ

• hypovolemia

• complete brach block

• retinopathia

• psoriasis

• pregnancy or breastfeeding

Related Conditions & MeSH terms

• Patients With COVID19

Intervention

Drug:
• Hydroxychloroquine
400mg per day during 10 days
• Azithromycin
500 mg per day during 5 days

Locations

Country	Name	City	State
Tunisia	Eshmoun Clinical Research Centre/ Hôpital Abderrahmen Mami-Ariana	Tunis

Sponsors (3)

Lead Sponsor	Collaborator
Abderrahmane Mami Hospital	Dacima Consulting, Eshmoun Clinical Research Centre

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvment or healing of clinical signs	no respiratory infectious signs	at the end of the study treatment - 1 month after inclusion
Primary	Evolution of clinical signs	Low respiratory signs with severity criteria	at the end of the study treatment - 1 month after inclusion