Protocol summary

Study aim
The effect of omega-3 on the outcome of the disease and the speed of recovery in patients with Covid19 infection is investigated.
Design
A control trial with a control group, with parallel, double-blind, randomized, phase 3 groups on 80 patients, used the block-making method with Randomization.com online software for randomization.
Settings and conduct
In this study, patients with Covid 19 referred to Amir Al-Momenin Hospital in Arak will be performed. A total of 80 patients with inclusion criteria will be divided into two groups of intervention and control after randomization. This study is a double-blind study and patients, clinical caregiver, outcome evaluator and data analyzer are not aware of the intervention type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 70 years, Positive PCR test , Oxygen saturation percentage less than 94, Respiratory rate more than 30 per minute. Exclusion criteria: severe heart disease, malignancy, ESRD, organ transplantation, pregnancy
Intervention groups
In the intervention group, 40 patients with Covid receive 19 omega-3 supplements of Golden Season fish oil containing 1200 mg of fish oil, at the rate of 6 g (5 capsules) orally per day for 5 days. In the control group, 40 patients with Covid 19 receive 5 placebo capsules similar to the main drug per day for 5 days.
Main outcome variables
Vital signs and percentage of blood oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210615051590N1
Registration date: 2021-07-15, 1400/04/24
Registration timing: prospective

Last update: 2021-07-15, 1400/04/24
Update count: 0
Registration date
2021-07-15, 1400/04/24
Registrant information
Name
Seyedahmadreza Mohadjerani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 7277
Email address
arm2022@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-22, 1400/04/31
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega-3 on disease outcome and length of stay in COVID-19 infected patients
Public title
Effect of omega-3 on disease outcome and length of stay in COVID-19 infected patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 70 years Positive PCR sample Blood oxygen level less than 94 Respiratory rate more than 30 per minute
Exclusion criteria:
Presence of serious heart disease , malignancy, ESRD, organ transplantation , pregnancy contraindications to the use of omega-3 pills
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be done using block randomization method and using online software (Randomization.com) and using 20 blocks of 4. A number of envelopes with aluminum wrappers (in order to obscure the contents of the envelopes) are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding in this study is that patients, clinical caregiver, outcome assessor and data analyst are not aware of the type of intervention and know the groups only on the basis of letters A and B. Medication and placebo containers each have a unique code that is only available to someone outside the study
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Payambar-e-azam Complex, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-05-30, 1400/03/09
Ethics committee reference number
IR.ARAKMU.REC.1400.041

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.01
ICD-10 code description
COVID-19 Disease

Primary outcomes

1

Description
Recovery of patients with Quid 19
Timepoint
Every day for up to 5 days
Method of measurement
Vital signs and blood oxygen saturation levels

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 40 patients with Covid 19 will consume omega 3 dietary supplement of 1200 mg Golden Seed Fish Oil (Karen Pharmacy) at a daily rate of 6 grams equivalent to 5 capsules orally for 5 days.
Category
Treatment - Drugs

2

Description
Control group: In the control group, 40 patients with Covid 19 will receive 5 placebo capsules similar to the main drug orally daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان امیرالمومنین
Full name of responsible person
Ahmadreza Mohajerani
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyedahmadreza Mohadjerani
Position
Internal Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3277 7277
Fax
Email
arm2022@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyedahmadreza Mohadjerani
Position
Internal Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3277 7277
Fax
Email
arm2022@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyedahmadreza Mohadjerani
Position
Internal Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3277 7277
Fax
Email
arm2022@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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