Trial Outcomes & Findings for Study to Evaluate Efficacy and Safety of "VIRACIDE" IN THE MANAGEMENT OF CORONA VIRUS DISEASE 2019 (COVID-19) (NCT NCT04596085)

Results Overview

The proportion of cases with National Early Warning Score reduction from 3 to 0 till discharge day between two groups. This score is associated with clinical risk and a decrease in score indicates a decrease in the risk to the patient and improvement in clinical condition.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

118 participants

Primary outcome timeframe

First treatment date up to discharge day, an average of 1 week

Results posted on

2021-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Product Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels . Fequency: 3 soft gels, two times every day after breakfast and dinner . Duration: 14 days+ SOC Therapy Investigational Product - ViraCide: Viracide	Placebo Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy Placebo - Starch Powder Soft gels: Starch Powder Soft gels
Overall Study STARTED	59	59
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Efficacy and Safety of "VIRACIDE" IN THE MANAGEMENT OF CORONA VIRUS DISEASE 2019 (COVID-19)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Product n=59 Participants Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels . Fequency: 3 soft gels, two times every day after breakfast and dinner . Duration: 14 days+ SOC Therapy Investigational Product - ViraCide: Viracide	Placebo n=59 Participants Ingredient, Placebo Ingredient Starch softgels. Frequency: 3 soft gels, two times everyday after breakfast and dinner . Duration:14 days + SOC Therapy Placebo - Starch Powder Soft gels: Starch Powder Soft gels	Total n=118 Participants Total of all reporting groups
Age, Continuous	58.53 years STANDARD_DEVIATION 5.81 • n=5 Participants	60.44 years STANDARD_DEVIATION 7.01 • n=7 Participants	59.48 years STANDARD_DEVIATION 6.41 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	59 Participants n=5 Participants	59 Participants n=7 Participants	118 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: First treatment date up to discharge day, an average of 1 week

The proportion of cases with National Early Warning Score reduction from 3 to 0 till discharge day between two groups. This score is associated with clinical risk and a decrease in score indicates a decrease in the risk to the patient and improvement in clinical condition.

Outcome measures

Outcome measures
Measure	Investigational Product n=59 Participants Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Placebo n=59 Participants Ingredient, Placebo Ingredient Starch softgels.
Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0	44 Participants	29 Participants

PRIMARY outcome

Timeframe: First treatment date up to day 7, i.e. up to 1 week

Proportion of cases with 7-point ordinal scale score reduction from 3 to 1 till day 7. This score is associated with clinical improvement and a decrease in score indicates improvement in patient's clinical condition.

Outcome measures

Outcome measures
Measure	Investigational Product n=59 Participants Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Placebo n=59 Participants Ingredient, Placebo Ingredient Starch softgels.
Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1	45 Participants	28 Participants

PRIMARY outcome

Timeframe: Time Frame: First treatment date up to 28 days

Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)

Outcome measures

Outcome measures
Measure	Investigational Product n=59 Participants Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Placebo n=59 Participants Ingredient, Placebo Ingredient Starch softgels.
Time to a Negative COVID-19 Nucleic Acid Testing	5.47 days Standard Deviation 0.49	6.97 days Standard Deviation 0.61

PRIMARY outcome

Timeframe: First treatment date up tp 28 days (28 days)

Population: The Rate of progression to the severity of the disease was not identifiable as most of the subjects were discharged on Day 7 or 8

Rate of progression to the severe/critical COVID-19 disease

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: First treatment date up to 28 days

Population: The Rate of progression to the severity of the disease was not identifiable as most of the subjects were discharged on Day 7 or 8

Rate of progression to the severe/critical COVID-19 disease

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time frame: 28 days

Incidence of ICU admissions

Outcome measures

Outcome measures
Measure	Investigational Product n=59 Participants Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Placebo n=59 Participants Ingredient, Placebo Ingredient Starch softgels.
ICU Admissions	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Subject survival in the trial

Outcome measures

Outcome measures
Measure	Investigational Product n=59 Participants Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Placebo n=59 Participants Ingredient, Placebo Ingredient Starch softgels.
Subject Survival	59 Participants	59 Participants

SECONDARY outcome

Timeframe: 28 days

Number of incidences of mechanical ventilation due to COVID-19 infection

Outcome measures

Outcome measures
Measure	Investigational Product n=59 Participants Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Placebo n=59 Participants Ingredient, Placebo Ingredient Starch softgels.
Incidence of Mechanical Ventilation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

To evaluate any decline in health condition due to comorbidity

Outcome measures

Outcome measures
Measure	Investigational Product n=59 Participants Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Placebo n=59 Participants Ingredient, Placebo Ingredient Starch softgels.
Change in Clinical or Laboratory Assessment of Comorbid Condition	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Percent of participants with worsening comorbid condition.

Outcome measures

Outcome measures
Measure	Investigational Product n=59 Participants Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Placebo n=59 Participants Ingredient, Placebo Ingredient Starch softgels.
Percent of Participants With Worsening Comorbid Condition	0 percentage Standard Deviation 0	0 percentage Standard Deviation 0

Adverse Events

Investigational Product

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Investigational Product n=59 participants at risk Experimental, Investigational Product Ingredient : ViraCide Dosage form softgels .	Placebo n=59 participants at risk Ingredient, Placebo Ingredient Starch softgels.
General disorders nausea	1.7% 1/59 • Number of events 1 • 28 days	3.4% 2/59 • Number of events 2 • 28 days
General disorders mouth ulcer	1.7% 1/59 • Number of events 1 • 28 days	3.4% 2/59 • Number of events 2 • 28 days
Ear and labyrinth disorders vertigo	1.7% 1/59 • Number of events 1 • 28 days	0.00% 0/59 • 28 days

Additional Information

Dr. Mahir Abduldaim

Natural Supplements LLC

Phone: +966557880299

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Confidential information during the course of the study and clinical development plan, except the information already existing in the public domain, and all results and reports obtained, collected, conceived, processed and developed pursuant to this Agreement, The INSTITUTION shall use confidential information for the sole purpose of providing services under this Agreement and shall not use confidential information for the INSTITUTION's own benefit at any time.
Publication restrictions are in place

Restriction type: OTHER