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USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19 (IVERCAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04425850
Recruitment Status : Completed
First Posted : June 11, 2020
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Hector E Carvallo, Eurnekian Public Hospital

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Covid19
Intervention Combination Product: Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)
Enrollment 229
Recruitment Details Health personnel
Pre-assignment Details

Once consent was signed, compliance with all the eligibility criteria verified, and inclusion of the subject decided, the investigator assigns corresponding treatment according to the randomization carried out.

It includes volunteers for both cohorts, provided they have test negative for COVID 19 in swabs obtained immediately before inclusion.

Arm/Group Title IVER+ IVER-
Hide Arm/Group Description Standard prophylactic measures and PPEs + iota carrageenan (nasal and buccal) and ivermectin (buccal) Standard prophylactic measures and PPE only
Period Title: Overall Study
Started 131 [1] 98 [2]
Completed 131 98
Not Completed 0 0
[1]
Standard prophylactic measures and PPE + iota carrageenan (nasal and buccal) and ivermectin (buccal)
[2]
Standard prophylactic measures and PPE only
Arm/Group Title IVER+ IVER- Total
Hide Arm/Group Description

Adults, both genders, no age limit. They will be provided with topical medication, to be used 5 times a day. PPEs used as suggested by OMS.

iota carrageenan: topical use on nasal mucosae

Ivermectin: Topical use on oral mucosae

Same as IVER+ They will follow PPEs suggestions, only. Total of all reporting groups
Overall Number of Baseline Participants 131 98 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 131 participants 98 participants 229 participants
42
(25 to 60)
39
(28 to 50)
40
(25 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 98 participants 229 participants
Female
70
  53.4%
72
  73.5%
142
  62.0%
Male
61
  46.6%
26
  26.5%
87
  38.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 98 participants 229 participants
Hispanic or Latino
131
 100.0%
98
 100.0%
229
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 98 participants 229 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
131
 100.0%
98
 100.0%
229
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Argentina Number Analyzed 131 participants 98 participants 229 participants
131
 100.0%
98
 100.0%
229
 100.0%
1.Primary Outcome
Title Number of Infected Subjects
Hide Description Number of participants testing positive for COVID-19 after inclusion in each arm
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Hispanic
Arm/Group Title IVER+ IVER-
Hide Arm/Group Description:
Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal)
Standard prophylactic measures and PPEs only
Overall Number of Participants Analyzed 131 98
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11
  11.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IVER+, IVER-
Comments Chi-squared test on the percentage of subjects who contracted COVID-19 in each arm
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Adverse Events Other Than Those Resulting From Contagion or Disease Progression
Hide Description Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Hispanic
Arm/Group Title IVER+ IVER-
Hide Arm/Group Description:
Standard prophylactic measures and PPE + Treatment with iota carragenan (nasal and buccal) and ivermectin (buccal only)
Standard prophylactic measures and PPE only
Overall Number of Participants Analyzed 131 98
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame 30 days
Adverse Event Reporting Description Medical examination Chart of adverse events filled in by subjects
 
Arm/Group Title IVER+ IVER-
Hide Arm/Group Description Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal). Standard prophylactic measures and PPEs only
All-Cause Mortality
IVER+ IVER-
Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)      0/98 (0.00%)    
Hide Serious Adverse Events
IVER+ IVER-
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/131 (0.00%)      0/98 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IVER+ IVER-
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/131 (0.00%)      11/98 (11.22%)    
Infections and infestations     
Contagion   0/131 (0.00%)  0 11/98 (11.22%)  11
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Héctor Carvallo
Organization: Eurnekian Public Hospital
Phone: 54144800949
EMail: hymcarvallo@hotmail.com
Layout table for additonal information
Responsible Party: Hector E Carvallo, Eurnekian Public Hospital
ClinicalTrials.gov Identifier: NCT04425850    
Other Study ID Numbers: IVERCAR
First Submitted: June 8, 2020
First Posted: June 11, 2020
Results First Submitted: August 13, 2020
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020