A Retrospective Study of COVID-19 Treatments | NCT04949230

Studies
A Retrospective Study of COVID-19 Treatments

NCT04949230

Sponsor

ProgenaBiome

Status

Completed

Last Update Posted

Feb 29, 2024Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Covid19
COVID-19 Pneumonia
COVID-19 Respiratory Infection
COVID-19 Acute Bronchitis
COVID-19 Acute Respiratory Distress Syndrome
COVID-19 Lower Respiratory Infection
SARS-CoV2 Infection
SARS-CoV-2 Acute Respiratory Disease

Interventions

No Intervention Used

Countries

United States

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 19, 2021Actual

Primary Completion Date

Feb 15, 2024Actual

Completion Date

Feb 15, 2024Actual

First Submitted Date

Jun 29, 2021

First Submission Date that Met QC Criteria

Jun 30, 2021

First Posted Date

Jul 2, 2021Actual

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

Feb 27, 2024

Last Update Posted Date

Feb 29, 2024Actual

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

Description Module

Brief Summary

Surveys administered to subjects who have recovered from COVID-19 to assess how effective their treatment was.

Detailed Description

Subjects who have recovered from COVID-19 will answer questions regarding the severity of their illness, symptoms experienced, what treatment they received, and how long they were ill.

Conditions Module

Conditions

Covid19
COVID-19 Pneumonia
COVID-19 Respiratory Infection
COVID-19 Acute Bronchitis
COVID-19 Acute Respiratory Distress Syndrome
COVID-19 Lower Respiratory Infection
SARS-CoV2 Infection
SARS-CoV-2 Acute Respiratory Disease

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 Patients		Subjects who have recovered from COVID-19	Other: No Intervention Used

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention Used	Other	There is no intervention in this study	COVID-19 Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survey Response	Answers given by subjects on their recovery from COVID-19	One hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
Male or female of 18 years of age or older
Diagnosis of COVID-19 infection by RT- PCR
Recovery from COVID-19

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

1. Refusal to sign informed consent form

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sabine Hazan, MD	ProgenaBiome	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ginger Aurella		Ventura	California	93003	United States

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided