NCT04989101

Brief Summary

This study will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 5, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

July 24, 2021

Last Update Submit

January 17, 2022

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

Nigelle 5CHCovid-19

Outcome Measures

Primary Outcomes (1)

  • SarsCOV2 Infection

    Respiratory infection

    one month

Secondary Outcomes (1)

  • Contamination

    one month

Study Arms (2)

Nigelle Group

ACTIVE COMPARATOR

The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month.

Drug: Nigella

Placebo Group

NO INTERVENTION

Follow-up should be done weekly for 1 month.

Interventions

NigellaDRUG

The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month.

Nigelle Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with an age\> 40 years

You may not qualify if:

  • Being positive for COVID or having contracted it previously
  • Immunocompromised (HIV, other ...)
  • Under chemotherapy
  • On immunosuppressants
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HU Sahloul, sousse, Tunisia

Sousse, Itinéraire Ceinture Cité Sahloul, 4054, Tunisia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

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

Study Officials

  • Riadh Boukef, professor

    CHU Sahloul, Sousse, Tunisia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

July 24, 2021

First Posted

August 4, 2021

Study Start

June 5, 2021

Primary Completion

July 31, 2021

Study Completion

August 31, 2021

Last Updated

January 24, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Data Statistical analysis

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The data will be available after publication
Access Criteria
all Criteria will be shared in the accepted article

Locations

TU(1)