NCT04974190

Brief Summary

A Nasal Spray device containing Dead Sea minerals and plant extracts, used to shorten duration and mitigate effects of Covid-19 infection in mild to moderate adult patients

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Status
unknown

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

July 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

July 21, 2021

Last Update Submit

July 21, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Covid-19 infection self-testing on days 2, 4 following testing positive on PCR test

    Testing using a self testing kit of the Quidel QuickView type

    First 7 days after testing positive on PCR test

  • Symptoms monitoring

    Monitoring any disease symptoms reported by patient

    First 7 days after testing positive on PCR test

Study Arms (2)

Patients treated with actual device with actual solution

ACTIVE COMPARATOR
Device: Nasal Spray Device

Patients treated with actual device with placebo solution

PLACEBO COMPARATOR
Device: Nasal Spray Device

Interventions

A Nasal Spray apparatus containing a liquid

Patients treated with actual device with actual solutionPatients treated with actual device with placebo solution

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A control group is allocated a placebo solution
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2021

First Posted

July 23, 2021

Study Start

August 1, 2021

Primary Completion

October 1, 2021

Study Completion

February 1, 2022

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share