Protocol summary

Study aim
Evaluation of the Pentoxifylline and Colchicine Effectiveness on Clinical Outcome of Patients with Covid-19 Infection
Design
Clinical trial with control group, with parallel, randomized, phase 3 groups per 100 patients. Excel software rand function was used for randomization.
Settings and conduct
Patients over 40 years of age with moderate to severe severity of covid19 patients admitted to Shafa Hospital in Khorramabad in the year 1400 eligible for inclusion in the study are randomly divided into two groups of intervention and control and their clinical consequences will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalized patients suspected to Covid19 infection who tested positive for PCR or despite the negative PCR test who have a strong clinical evidence plus typical radiographic sing of Covid19 that is difficult to justify their symptoms based on other diseases. Exclusion criteria: Active peptic ulcer Pregnancy and lactation History of colchicine or pentoxifylline allergy Concomitant use of protease inhibitors, strong inhibitors or inducers of CYP3A4 or pgp drugs, statin other than rosuvastatin Occurrence of side effects Fauvism History of alcohol use Retinopathy Neuromuscular disease Severe renal and hepatic failure Active bleeding ihemorrhage Chronic diarrhea or malabsorption History of heart disease Dissatisfaction with the company
Intervention groups
The intervention group received a 0.5 mg daily of colchicine and 400 mg Pentoxifylline every 12 hours in addition to the standard treatment regimen The control group receiving standard treatment regimen
Main outcome variables
Duration of hospitalization Survival rate of 28 days from the time of hospitalization The duration of recovery or the duration of entry into the disease stage

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200721048159N3
Registration date: 2021-06-03, 1400/03/13
Registration timing: prospective

Last update: 2021-06-03, 1400/03/13
Update count: 0
Registration date
2021-06-03, 1400/03/13
Registrant information
Name
Forouzan Ahmadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0239
Email address
ahmadpoor.f@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Pentoxifylline and Colchicine Effectiveness on Clinical Outcome of Hospitalized Patients With moderate to Severe Covid-19 Infection
Public title
The Effectiveness of Pentoxifylline and Colchicine in the Treatment of Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients suspected to Covid19 infection SpO2 less than 93% The presence of respiratory symptoms (including shortness of breath, pain and pressure in the chest) older than 40 years
Exclusion criteria:
Active peptic ulcer Pregnancy and lactation History of colchicine or pentoxifylline allergy Concomitant use of protease inhibitors, strong inhibitors or inducers of CYP3A4 or pgp drugs, statin other than rosuvastatin Occurrence of side effects Fauvism History of alcohol use Retinopathy Neuromuscular disease Severe renal failure and GFR less than 30 ml/min Severe hepatic impairment (bilirubin higher than 2 mg/dL and albumin less than 2.8 g/dL) Active bleeding including intracerebral hemorrhage or retinal hemorrhage Chronic diarrhea or malabsorption History of heart disease (heart failure, ventricular arrhythmia, right or left heart block, QTc more than 480 milliseconds) Dissatisfaction with the company
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the 4-layer randomized block method is used to randomly assign patients to two groups A (pentoxifylline and colchicine) and group B (control group). To do this, first by considering the classes as the age range (65-40) and over 65 years within each class, a list of blocks is written and numbers are assigned to them. (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)). Then, using a table of random numbers, the numbers between one to 6 (for example, 1,4,5, etc.) are randomly selected, and finally the list of treatment assignments will be formed based on a sequence of letters A and B.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Lorestan, Khorramabad, 3 km of Khorramabad Road, Tehran, Pardis University Complex, Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences, Office of Research Ethics Committee
City
Khorramabad
Province
Lorestan
Postal code
381351698
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.LUMS.REC.1399.362

Health conditions studied

1

Description of health condition studied
covid 19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Duration of hospitalization
Timepoint
7 -14 days
Method of measurement
Based on patient file information

Secondary outcomes

1

Description
The duration of recovery or the duration of entry into the disease stage
Timepoint
7-14 days
Method of measurement
Based on patient file information

2

Description
Survival rate of 28 days from the time of hospitalization
Timepoint
28 days after starting the study
Method of measurement
Interview with the patient or her family

3

Description
the amount of arterial oxygen saturation
Timepoint
Daily
Method of measurement
Using a device to measure the percentage of oxygen saturation

4

Description
Frequency of transfer to intensive care unit
Timepoint
Daily
Method of measurement
Under supervision

Intervention groups

1

Description
Intervention group: Pentoxifylline group receiving 400 mg every 12 hours (Amin Pharmaceutical Company) plus colchicine half a mg every day (Mofid Pharma Pharmaceutical Company) orally in addition to the standard treatment regimen according to the national protocol (Ramsavier and corticosteroids) For 7-14 days depending on the patient's clinical condition
Category
Treatment - Drugs

2

Description
Control group: Standard treatment regimen according to the national protocol
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Forouzan Ahmadpour
Street address
Lorestan, Khorramabad, Piroozi St., Shafa Hospital
City
Khorramabd
Province
Lorestan
Postal code
133456789765432
Phone
+98 66 3326 5020
Email
info@shafahospital.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences
Full name of responsible person
Ebrahim Falahi
Street address
Lorestan, Khorramabad, Kamalvand, km 4 of Khorramabad road
City
Khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0239
Email
falahi.e@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Lorestan 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Lorestan, Khorramabad, Kamalvand, km 4 of Khorramabad road
City
Khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0239
Email
ahmadpourforoz@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Lorestan, Khorramabad, Kamalvand, km 4 of Khorramabad road
City
Khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0239
Email
ahmadpourforoz@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Lorestan, Khorramabad, Kamalvand, km 4 of Khorramabad road
City
Khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0239
Email
ahmadpourforoz@yahoo.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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