| Study Title | A Multi-Centric, Open label, Two Arm Randomized, Pivotal Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications |
| Sponsor | Not Applicable |
| Principal Investigator | Name: Not Applicable Telephone: Not Applicable E-mail: Not Applicable |
Dear Participant,
We would like to invite you to participate in a pivotal phase 2 study aimed to evaluate the safety and efficacy of the product: Itolizumab which is meant for the treatment of Covid 19. We wish you to read this informed consent form carefully and then arrive at a decision on whether to enrol for this pilot study. This informed consent form gives you details about the study. You can ask your study doctor about anything related to the study which you do not understand. The study doctor shall be happy to resolve your queries until you are satisfied. We also advise you to talk to family and/ friends to help you to make a final decision for your participation in this study. Once you have understood the details of the study and confirm your willingness to participate in the study, you shall be asked to sign this consent form. You will be given a copy of the signed informed consent form for your records too.
This Informed Consent form has two parts:
- Patient Information sheet: It has the details about the Pivotal Phase 2 trial
- Certificate of consent: It shall have your signatures if you agree to take part in the trial
A) Patient Information sheet:
About this Pivotal Phase 2 study:
The aim of this study is to elucidate the safety and effectiveness of Itolizumab in the treatment of Covid 19. Coronavirus disease (Covid 19) is an infectious disease caused by SARS CoV 2 virus and it affects different people in different ways. Most infected people will develop mild to moderate symptoms and recover without hospitalisation. Coronavirus disease 2019 (COVID-19) progresses to respiratory complications as consequence of the exaggerated immune response of the host, producing a pro-inflammatory cytokine storm syndrome (i.e.: IL-6, TNF) and cytopenia, with a high mortality rate. However, not being sufficient to reduce the rising mortality by COVID-19 other interventions to immunomodulate the life-threatening hyperinflammation are urgently needed. Therefore, the proposal for use of an anti-CD6 monoclonal antibody (Itolizumab) for the treatment of the COVID-19 cytokine storm syndrome complication. Itolizumab in COVID-19 patients will control the pro-inflammatory cytokine storm syndrome, thus reducing the morbidity and mortality.
Participant Selection:
We would like you to know that we have selected you to be a part of this study as you satisfy one or more of the below listed criteria.
- Patients of Covid 19 hospitalized due to clinical worsening of Covid 19 infection.
- Patients of either sex between 18 years and above.
- Willing and able to participate for up to 30 days.
Study process:
We plan to recruit 30 participants in this study which shall be conducted at _____________ and you shall be assigned to either of the study groups. One group shall receive Itolizumab and the other group shall receive ______________________
You shall be evaluated at the study site after 12 hours, 24 hours,7days, 14 days and 30 days after your first visit. In total, your clinical parameters will be assessed up to 1 month. At each visit the study doctor will examine you. Some blood tests shall be carried out on each evaluation. ___ ml of blood will be collected from your arm with a needle and syringe. You may experience slight pain the blood collection site can become red and swollen. It’s not harmful and usually goes away in few days. Radiological investigations such as Xray and Chest CT scan shall be performed on the 1st,24 hours, 7 days for clinical evaluation. These investigations are vital to monitor your condition and to access the efficacy and safety of the treatment offered to you.
Your role in the study process:
If you decide to participate in this study, you shall have to answer some questions about your health and inform the study doctor about any medications that you are taking honestly. Once the doctor is convinced about your participation, you will be enrolled in the study. The study involves evaluation of Itolizumab for which your symptoms and the blood levels and radiological investigations shall be monitored.
You will either be given Itolizumab or ___________
ASSIGNMENT TO A GROUP
If you decide to participate then you will be “randomized” into one of the groups described below. Randomization means that you are put into a group by chance (like flipping a coin). There is no way to predict which group you will be assigned to. You will have an equal chance of being placed in either group. Neither you nor your doctor can choose what group you will be in. You will be told which treatment you are to get.
Group 1 ( Itolizumab + Best supportive care)
Participants will receive the experimental drug Itolizumab + antivirals, antibiotics, oxygen therapy etc
Group 2 (Best supportive care)
Participants will receive the experimental drug Itolizumab + antivirals, antibiotics, oxygen therapy etc.
You are not allowed to take any other medications apart from the ones prescribed by your doctor. If you require to take any treatment, you must ask your doctor before taking that treatment. You will be required to return the unused product on your final visit to the study site. This would enable correct assessment of the study results. Once you are enrolled in the study, you will be required to follow the instructions as stated in the below chart.
Benefits of participation in the study:
Itolizumab in COVID-19 patients will control the pro-inflammatory cytokine storm syndrome and help in reducing the morbidity and mortality.
If you agree to take part in this study, there may or may not be direct benefit to you. We hope the information learned from this study will help other patients in the future.
Compensation and Costs to participate in the study:
You shall not be paid for your participation in the study.
It is possible that the research conducted using your study data may eventually lead to the development of new diagnostic tests, new drugs or other commercial products. There are no plans to provide payment to you if this happens.
In an unlikely event, if you experience any study related injury, the sponsor shall provide monetary compensation to you. Study related injury is any physical injury or illness occurring due to your participation in the study. You are eligible for the financial compensation related to study injuries due the following reasons:
- Adverse effects of the study product.
- Any procedure involved in this study.
- Violation of the approved protocol, scientific misconduct or negligence by the sponsor or investigator.
- Failure of the study product to provide intended therapeutic benefit.
- Use of placebo in placebo- controlled trial.
- Adverse events due to concomitant medications excluding standard care, necessitated as a part of approved protocol.
You shall be covered under insurance by the sponsor of this study for study related injuries. Direct payment for lost wages, expenses other than medical care or pain and suffering will not be provided.
Your safety is of prime concern to us. If you are injured or have a medical problem due to your participation in study, you should contact one of the persons listed in the end of the consent form.
Risks while participation in study:
Itolizumab has been administered to patients with RA or Psoriasis and has been reported to be well tolerated and safe. However mild to moderate incidences of fever, pain and swelling at the injection site and upper respiratory tract infections can be reported.
Participating on this study will put you at risk for the side effects listed above. You should discuss these with your doctor. As with any experimental drug additional unexpected and sometimes serious side effects are a possibility. Your doctor will watch you closely to see if you have side effects. When possible, other drugs will be given to you to make side effects less serious and more tolerable.
There can be a possibility of failure of investigational product to provide intended therapeutic effect in spite of best clinical measures been adapted.
ALTERNATIVE TREATMENTS
You do not have to take part in this study in order to receive treatment/care; other options may include, but are not limited to:
- No therapy currently.
- Best Supportive Care (BSC). This type of care does not treat the coronavirus directly, but instead tries to improve how you feel. Best Supportive Care tries to keep you as active and comfortable as possible.
- Other experimental studies may be available if you do not take part in this study, please talk to your study doctor or usual doctor (if different from the study doctor) about the known benefits and risks of these other options before you decide to take part in this study. Your doctor can also discuss with you what will happen if you decide not to undertake any treatment at this time.
Statement of Confidentiality:
Once you decide to take part in the study and sign the consent form, you allow us to use your personal and medical details for the study. We shall ensure that the best measures are adopted to protect your confidentiality.
Your personal and medical details related to study will be recorded, reported, analysed and stored for the study period. After the study period is over, your details shall be stored for a certain period of time as per government directives and later destroyed once the period gets over. Your study details will be shared with the study doctors, study researchers, Sponsors of the study, Ethics committee members and statisticians to analyse your study details. No other person is authorised to access your personal and medical details. Your identity and personal information shall be securely coded and stored in file. You can access the same if nay need arises to make changes in your contact information or if you may want to look into your study details at any point of time. Your identity shall not be revealed in any of the study documents. These codes shall be broken only during emergencies – ex. if you develop any side effects during the study.
Voluntary participation:
Your participation in the study is purely voluntary. You have the liberty not to choose to be the part of the study or the leave the study at any point of time. This shall not result into any penalties. You will not lose any penalties otherwise to which you are entitled to and your decision will not affect your medical care access in the future.
Removal from study:
Your participation in the study may be stopped by the study doctor at any given point of time if the doctors feel it to be in the best medical interest. This shall not result into any penalties or loss of benefits to which you are entitled to.
Leaving the study:
During the study period, if you wish not to continue your participation in the study, you may inform your study doctor. You may require some medical tests to ensure that you are fine. Your decision to leave the study shall not affect your healthcare access or your relationship with the study doctor or with the institution. You will not lose any benefits you are entitled to otherwise.
Responsibilities of Participants:
- You will have to undergo the study specific tests.
- You shall have to meet your study doctor during every visit.
- You will inform your study doctor about any side effects at any given point of time.
- You shall interact with the study team over phone calls to provide an update about your health.
- You shall share with us your name, contact details and alternative contact details.
- You will not be eligible to participate in any other study during the course of this study.
Contact details of authorized personnel for any queries during the study process:
A] For queries related to the study:
| Role in the Study | Name | Contact Details |
| Principal Investigator | Not Applicable | Ph: Not Applicable Fax: Not Applicable |
| Sub-Investigator | Not Applicable | Ph: Not Applicable Fax: Not Applicable |
B] For queries related to your rights as a participant in a Clinical Study:
| Role in the Study | Name | Contact Details |
| Chairperson, Ethics Committee | Not Applicable | Ph: Not Applicable Fax: Not Applicable |
| Member Secretary, Ethics Committee | Not Applicable | Ph: Not Applicable Fax: Not Applicable |
C] For making a claim for financial compensation in a case of study related to injury or death:
| Role in the Study | Name | Contact Details |
| Sponsor | Authorized Signatory: Not Applicable Address: Not Applicable | Ph: Not Applicable Fax: Not Applicable |
| CRO | Authorized Signatory: Not Applicable | Ph: Not Applicable Fax: Not Applicable |
B) Certificate of Informed Consent:
Informed Consent form to participate in the clinical trial
Study Title: Not Applicable
Study Number: Not Applicable
Subject’s Initials: Not Applicable
Subject’s Name: Not Applicable
Date of Birth/Age: Not Applicable
Address of the Participant: Not Applicable
Qualification: Not Applicable
Occupation: Student or Self-Employed or Service or Housewife or Others (Please click as appropriate): Not Applicable
Annual Income of the subject: Not Applicable
Name and address of the nominees and his relation to the subject (for the purpose of compensation in case of trial related death): Not Applicable
Place Initials in the box (Subject)
(i) I confirm that I have read and understood the information Sheet dated ___________ for the above study and have had the opportunity to ask questions. [ ]
(ii) I understand that my participation in the study is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. [ ]
(iii) I understand that the Sponsor of the clinical trial, others working on the Sponsor’s behalf, the Ethics Committee and the regulatory authorities will not need my permission to look at my health records both in respect of the current study and any further research that may be conducted in relation to it, even if I withdraw from the trial. I agree to this access. However, I understand that my identity will not be revealed in any information released to third parties or published. [ ]
(iv) I agree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purposes [ ]
(v) I agree to take part in the above study. [ ]
Signature (or Thumb impression) of the Subject/Legally Acceptable Representative: Not Applicable
Date: Not Applicable
Signatory’s Name: Not Applicable
Signature of the Investigator: Not Applicable
Date: Not Applicable
Study Investigator’s Name: Not Applicable
Signature of the Witness: Not Applicable
Date: Not Applicable
Name of the Witness: Not Applicable
Copy of the Patient Information Sheet and duly filled Informed Consent Form shall be handed over to the subject his or her attendant.
Dr. Sushmita Ganguli 
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