Why is PROTECT trial being conducted?
This trial is being conducted in order to find out drugs of proven value against COVID-19. COVID-19 is a disease condition caused by a virus called SARS-COV-2 (coronavirus). More than 95 % of the patients recover spontaneously from this disease without requiring hospital admission but those who develop severe symptoms require hospital admission and may need oxygen or mechanical ventilation. This study aims to find out treatment modalities for COVID-19.
What drugs are under trial in this study?
The drugs under trial in various arms of this study are hydroxychloroquine, oseltamivir and azithromycin alone and also in combination.
Who is doing this trial?
This study is being conducted and sponsored by University of Health Sciences along with its academic and research partners all across Pakistan.
What happens when I agree to take part in the study?
After the provision of detailed information regarding the trial, an informed consent shall be sought. After that your demographic details shall be obtained and then you shall be allocated a drug regimen by the computer randomly. The trial duration is two weeks and the treatments are given orally and on specific days and your blood samples shall be drawn in order to perform tests and they shall be recorded by the medical team taking care of you. A nasal swab or multiple swabs shall also be obtained during the course of the study in order to find out the viral load of SARS-COV2 using PCR.
What are the potential benefits of participating in PROTECT trial?
At this point in time there is no indication that these drugs may be proven beneficial in context of COVID-19. These modalities may or may not improve your disease but the results of this study should be helpful for future patients.
Do I have to pay to be in PROTECT trial?
The trial treatment regimens being offered are free and neither you nor the healthcare professionals involved in this study will be paid in order to take part in this study.
What is informed consent?
It is the process by which the patient is informed about the details of the trial before obtaining consent regarding participation in the trial. The patient is explained regarding possible risks and benefits and on after the patients has fully understood all the details, consent regarding participation is sought.
What are the risks of being in the study?
Apart from the side effects which are known and mentioned on the brochure that shall be provided to every patient, there may be risk of developing drug reaction but that is highly unlikely. Women who are pregnant are not included in the trial due to safety concerns. When you are allocated a study group then your doctor is intimated regarding the medication and regimen you are getting so that they can monitor general and specific side effects.
If I have any problems or questions, who can I call?
In case there are any questions then you can talk to the hospital medical team that is taking care of you. Apart from that, all essential information regarding the trial are mentioned on trial website: www.theprotect.com.pk
Can I stop the study treatment and end my participation prematurely?
If a participant or the doctor want to stop the study treatment before the course has been completed, then they are free to do so.
What about my data privacy?
The data shall be controlled by University of Health Sciences. Data shall be gathered from various trial sites on Clinical Research Forms and relayed back to UHS trial monitoring room where it shall be compiled and encoded for scientific analysis. For this purpose, health professionals involved in conducting this trial may see your scientific/clinical data in order to ascertain certain scientific mechanisms but they shall not be able to identify you. Only the person who contacts you from the trial sponsor organization shall have access to information that identifies you. Same person shall be responsible for future contacts, follow-ups and also shall send you copy of the result. Your personal data may be kept by the sponsor organization for up to 25 years after the end of the study. The data shall be protected against unauthorized access, unlawful use, accidental loss corruption and destruction. The data shall be stored on secure devices with active encryption. Only a limited number of people will have access to the data. The data shall only be used for the purpose of carrying out research analysis and scientific reporting pertaining to this trial. you can request the right to access your data at any time during or after trial, you can also request corrections as well. For further queries in this regard you can contact via email at: firstname.lastname@example.org