The effect of cinnora supplement therapy in patients with severe form of COVID-19
Design
Clinical trial with control group, parallel, and randomized groups on 80 patients. Random number table was used for randomization.
Settings and conduct
Study place: Shahid Beheshti Hospital, Kashan. Methods: Patients are randomly divided into two groups (case-control) according to a random number table. The study is a one-way blind study. The clinical caregiver dose not know how to assign patients to the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with definitive diagnosis of COVID-19, and patients over 18 years.
Exclusion criteria: Patient underwent tumor necrosis factor alpha inhibitors due to previous inflammatory disease, positive purified protein derivative test and active bacterial infection
Intervention groups
Patients in both groups receive standard treatment (corticosteroids and remdesivir and ceftriaxone antibiotics and oxygen therapy). Then one group receives cinnora medicine and one group does not.
Patients treated with cinnora ampoules receive a dose of 80 mg subcutaneously. If needed, they will receive another 40 mg of cinnora after one week. Before receiving this drug, a purified protein derivative skin test should be performed and a chest x-ray should not indicate infection. In patients of both groups, clinical symptom such as oxygen saturation is recorded daily and laboratory criteria including C reactive protein will be measured daily for up to two weeks.
Main outcome variables
Arterial oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180209038673N6
Registration date:2022-04-26, 1401/02/06
Registration timing:retrospective
Last update:2022-04-26, 1401/02/06
Update count:0
Registration date
2022-04-26, 1401/02/06
Registrant information
Name
Robab Sheikhpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 5958
Email address
r.sheikhpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of cinnora supplement therapy in patients with severe form of COVID-19
Public title
The effect of cinnora supplement therapy in patients with severe form of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years
Patients with definitive diagnosis of COVID-19
Exclusion criteria:
Patients who treated with tumour necrosis factor α inhibitors due to previous inflammatory diseases.
Positive purified protein derivative skin test.
Active bacterial infection.
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the intervention and control groups is done based on quadruple blocks in Excel software. In this software, the intervention and control groups are placed alternately. In the next column, there are quadruple blocks. At the end, the random digits created by the software RND0 function are placed. We then arrange the numbers based on block columns and random values.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, clinical caregiver will not aware about prescription drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Shahrdari Street, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2021-12-06, 1400/09/15
Ethics committee reference number
IR. KAUMS. REC.1400.049
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Improvement of clinical symptoms (arterial oxygen)
Timepoint
Daily evaluation of clinical signs for up to two weeks
Method of measurement
Pulse oximeter
Secondary outcomes
1
Description
C-reactive protein (CRP)
Timepoint
Daily evaluation of clinical signs for up to two weeks
Method of measurement
CRP kit
Intervention groups
1
Description
Intervention group: Patients in the intervention group receive standard treatment, including corticosteroids (Abidi Company), 200 mg remdisiver (Ronak Company). Then, they receive 100 mg remdesivir for 5 days and 1 gr ceftriaxone antibiotics (Dana Company), and oxygen therapy. Then, patients receive 80 mg cinnora ampule, subcutaneously (CinnaGen Company). If needed, they will receive 40 mg of cinnora after one week.
Category
Treatment - Drugs
2
Description
Control group: Patients in the intervention group receive standard treatment, including corticosteroids (Abidi Company), 200 mg remdisiver (Ronak Company). Then, they receive 100 mg remdesivir for 5 days and 1 gr ceftriaxone antibiotics (Dana Company), and oxygen therapy.