Corona Virus Disease 2019 (COVID-19)NCT04690920
Theranostic Implication of Complementary Medicines Against Interleukin Receptors and Gp-130 Proteins
A study testing Tocilizumab in people with Corona Virus Disease 2019 (COVID-19), run by University of Lahore at 1 site in Pakistan.
Trial summary
IL-6 is an inflammatory marker, secrete by the cells in many pathological conditions like COVID-19 pneumonia. Interleukin 6 bind with its receptors (IL-6R) on cells surface and recruited a protein for its activation known as gp-130. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corona Virus Disease 2019 (COVID-19)
- What is being tested?
- Tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Jul 2020to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted diagnosed cases of COVID-19 infection on real time polymerase chain reaction (RT-PCR) Both male and female were included All participants were on oxygen therapy
Who cannot join
- Asthmatics pulmonary fibrosis chronic obstructive pulmonary disease (COPD) Allergic to remdesivir Allergic to Actemra Refused to take consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Theranostic Implication of Complimentary Medicines Against IL-6/Gp-130 in COVID-19.: An in Vitro and in Silco Approach
IL-6 is an inflammatory marker, secrete by the cells in many pathological conditions like COVID-19 pneumonia. Interleukin 6 bind with its receptors (IL-6R) on cells surface and recruited a protein for its activation known as gp-130. Activated receptors send signals to nucleus through secondary messenger system and up regulate the expression of IL-6/GP130 domain. Total of two hundred (n=200) participants were included in the current study and divided equally in four groups. Group B is given Tocilizumab and Group C is treated with Remdesivir along with the approved standard treatment. Group D is only Given standard therapy and Group A constituted normal healthy age and sexed matched participants. Levels of gp-130 were estimated by commercially available ELISA kit. To estimate the relationship of severity of disease with gp-130 and IL-6 Pearson's correlations was used. Sensitivity and specificity for what purpose
- Conditions
- Corona Virus Disease 2019 (COVID-19)
- Being tested
- Tocilizumab
- Keywords
- corona virus disease 2019 (COVID-19), Tocilizumab, Remdesivir, Interleukin receptor-6, glycoprotein-130, receptor blocker
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called Remdesivir, Standard treatment with Antibiotic, oxygen, Vitamin C, Statins, No treatment is given to control group
Comparison of drugs, Tocilizumab, Remdesivir, standard treatment with controls
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Tocilizumab | Experimental | Not described Receives: Drug: Tocilizumab |
| Remdesivir | Experimental | Not described Receives: Drug: Tocilizumab |
| Standard Treatment | Active comparator | Not described Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen
Measured: 7 days
Secondary outcomes (3)
Hospital stay
Measured: 15 days
Oxygen demand
Measured: 7-15 days
Viral load
by RT-PCR
Measured: 7-15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start23 Jul 2020
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus Disease 2019 (COVID-19)Studies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Muhammad Mansoor Hafeez, University of Lahore
- Investigators
- Arif Malik, PhD, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690920
- Sponsor's protocol ID
- UOL/IMBB/2020/118
- Status last verified
- Dec 2020
- First submitted
- 19 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: statistical analysis, results
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theranostic Implication of Complimentary Medicines Against IL-6/Gp-130 in COVID-19.: An in Vitro and in Silco Approach
- ClinicalTrials.gov ID
- NCT04690920
- Acronym / sponsor ID
- UOL/IMBB/2020/118
- Conditions
- Corona Virus Disease 2019 (COVID-19)
- Keywords
- corona virus disease 2019 (COVID-19), Tocilizumab, Remdesivir, Interleukin receptor-6, glycoprotein-130, receptor blocker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IL-6 is an inflammatory marker, secrete by the cells in many pathological conditions like COVID-19 pneumonia. Interleukin 6 bind with its receptors (IL-6R) on cells surface and recruited a protein for its activation known as gp-130. Activated receptors send signals to nucleus through secondary messenger system and up regulate the expression of IL-6/GP130 domain. Total of two hundred (n=200) participants were included in the current study and divided equally in four groups. Group B is given Tocilizumab and Group C is treated with Remdesivir along with the approved standard treatment. Group D is only Given standard therapy and Group A constituted normal healthy age and sexed matched participants. Levels of gp-130 were estimated by commercially available ELISA kit. To estimate the relationship of severity of disease with gp-130 and IL-6 Pearson's correlations was used. Sensitivity and specificity for what purpose
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Tocilizumab | Experimental | Drug: Tocilizumab |
| Remdesivir | Experimental | Drug: Tocilizumab |
| Standard Treatment | Active comparator | Drug: Tocilizumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Admitted diagnosed cases of COVID-19 infection on real time polymerase chain reaction (RT-PCR) Both male and female were included All participants were on oxygen therapy
Key exclusion criteria (1 listed)
- Asthmatics pulmonary fibrosis chronic obstructive pulmonary disease (COPD) Allergic to remdesivir Allergic to Actemra Refused to take consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: Remdesivir, Standard treatment with Antibiotic, oxygen, Vitamin C, Statins, No treatment is given to control groupComparison of drugs, Tocilizumab, Remdesivir, standard treatment with controls | Drug | Remdesivir, Standard Treatment, Tocilizumab |
Primary outcome
Ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen
Time frame: 7 days
3 secondary outcomes
Hospital stay
Time frame: 15 days
Oxygen demand
Time frame: 7-15 days
Viral load
Time frame: 7-15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: Undecided. statistical analysis, results
Related trials for Corona Virus Disease 2019 (COVID-19)
RecruitingObservational study
Corona Virus Disease 2019 Cohort Study
COVID-19 Pneumonia, COVID-19 Pandemic
Not yet recruitingPhase 2
Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells
Corona Virus Infection, Covid19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arif Malik, PhD study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tocilizumab in people with Corona Virus Disease 2019 (COVID-19), run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.