Angiotensin Converting Enzyme Inhibitors in Treatment of... | NCT04345406

Studies
Angiotensin Converting Enzyme Inhibitors in Treatment of Covid 19

NCT04345406

Sponsor

Tanta University

Status

Not yet recruiting

Last Update Posted

Apr 14, 2020Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

COVID

Interventions

ACEIs
Conventional treatment

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2020Estimated

Primary Completion Date

Dec 1, 2029Estimated

Completion Date

Dec 1, 2029Estimated

First Submitted Date

Apr 11, 2020

First Submission Date that Met QC Criteria

Apr 11, 2020

First Posted Date

Apr 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2020

Last Update Posted Date

Apr 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sherief Abd-Elsalam, assistant professor of tropical medicine and infectious diseases, Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACEIs	Experimental	ACEIs with conventional treatment for COVID19	Drug: ACEIs Drug: Conventional treatment
Conventional treatment of COVID19	Experimental	Conventional treatment of COVID19	Drug: Conventional treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACEIs	Drug	Captopril or enalapril	ACEIs	Enalapril, Captopril

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients with virological cure	number of patients with virological cure	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients infected with covid 19

Exclusion Criteria:

allergy or contraindications to the drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam	Contact	+201147773440		sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Sherief Abd-Elsalam, ass. prof.	Tanta University Faculty of medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University		Tanta		35111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004656	Enalapril
D002216	Captopril
D002738	Chloroquine

Ancestor Terms

ID	Term
D004151	Dipeptides
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided