COVID 19Phase 2NCT04461340
Efficacy and Safety of Sirolimus in COVID-19 Infection
A Phase 2 study testing Sirolimus in people with COVID 19, run by Alexandria University at 1 site in Egypt.
Trial summary
This research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19
- What is being tested?
- Sirolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2020to 30 Nov 2020
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (˃18 years) COVID-19 positive patients (confirmed by PCR).
- Moderate infection ( pneumonia ± leucopenia or lymphopenia ).
Who cannot join
- Severe or life threatening COVID infection: Severe disease is defined as: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours. Life threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure .
- Pregnant or lactating females.
- Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.
- Allergy or hypersensitivity to sirolimus.
- Taking immunosuppressive drugs.
- Glomerular filtration rate (GFR) < 30 ml/min by CKD-EPI equation.
Show all 11Show fewer
- liver cirrhosis .
- Decompensated heart failure.
- known active tuberculosis (TB) or history of incompletely treated TB.
- Uncontrolled systemic bacterial or fungal infections.
- Drugs that may affect sirolimus level: antifungals, diltiazem, verapamil, nicardipine, phenytoin, phenobarbital, rifampicin, carbamazepine.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Alexandria university, Egypt
Alexandria, 21526
Mohamed Mamdouh Elsayed, MD, 00201068055103, dr_mohamedmamdouh87@yahoo.com
About this study
Official title: Efficacy and Safety of Sirolimus for Treating COVID-19 Infection
This research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection
Read the detailed description
In early December 2019, several pneumonia cases of unknown origin were observed in Wuhan (China). A novel enveloped RNA β coronavirus was isolated and named severe acute respiratory syndrome coronavirus 2 (SARSCoV- 2). The new virus rapidly spread across China and worldwide. On March 11th 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) a pandemic. As of 1July 2020, COVID-19 has been confirmed in 10,357,662 individuals globally with deaths reaching 508,055 with a morality of 5.37%. Egypt has 68,311 confirmed cases and 2935 deaths.
The virus mainly spreads through respiratory droplets from infected patients. The clinical spectrum of COVID-19 infection ranges from asymptomatic forms to severe pneumonia requiring hospitalization and isolation in critical care units with the need of mechanical ventilation due to acute respiratory distress syndrome (ARDS). Main symptoms include fever, fatigue and dry cough. Common laboratory findings include lymphopenia and elevated lactate dehydrogenase levels. Platelet count is usually normal or mildly decreased. C reactive protein (CRP) and erythrocyte sedimentation rate (ESR) are usually increased while procalcitonin levels are normal and elevation of procalcitonin usually indicates secondary bacterial infection. Ferritin, D-dimer, and creatine kinase elevation is associated with severe disease. Chest computed tomographic scans show a typical pattern of bilateral patchy shadows or ground glass opacity.
Severe COVID-19 conditions are usually due to an aggressive inflammatory response known as "cytokine storm" that is characterized by the release of a large amount of pro-inflammatory cytokines. Lung injury, multiorgan failure, and unfavorable prognosis of severe COVID-19 infection have been attributed mainly to the cytokine storm state.
Many proinflammatory cytokines elevate in COVID-19 patients including interleukin (IL)-1, IL-6, IL-8, IL-10, tumor necrosis factor (TNF)-α and interferon( IFN)-Ȣ stimulating immune cells to invade sites of infection causing endothelial dysfunction, vascular damage, alveolar damage and ARDS. Cytokine storm has been reported in several viral infections including influenza H5N1 virus, influenza H1N1 virus, and the two coronaviruses highly related to COVID-19; "SARS-CoV" and "MERSCoV".
Currently, there is no vaccine and/or specific therapeutic drugs targeting the SARS-CoV-2. Hence, it remains a major challenge to decide what potential therapeutic regimens to prevent and treat severe COVID-19 infections. Effective vaccines are essential to combat against the extremely contagious SARS-CoV-2. Until we have specific vaccines or therapeutic drugs targeting SARS-CoV-2, "repurposed" drugs have been used to treat COVID-19 patients. At present, treatment of SARS-CoV-2 infection are mainly repurposing the available therapeutic drugs and based on symptomatic conditions. Considering ARDS, followed by secondary infections, antibiotics, antiviral therapy, systemic corticosteroids, and anti-inflammatory drugs (including anti-arthritis drugs) are often used in the treatment regimens. Neuraminidase inhibitors, RNA synthesis inhibitors, convalescent plasma, and traditional herbal medicines have also been utilized in the treatment of COVID 19. Nevertheless, the efficacy of these treatment regimens remains to be verified by appropriately designed clinical trials. Sirolimus, also known as rapamycin, is an immunosuppressant that is used to prevent organ transplant rejection by inhibiting mammalian target of rapamycin (mTOR) kinase. mTOR plays a key role in viral replication. In an in vitro experiment, sirolimus has been shown to affect PI3K/AKT/mTOR pathway which inhibited MERS-CoV activity. Studies of patients hospitalized with influenza can further shed light on the antiviral effect of sirolimus. In a randomized clinical trial conducted on 38 patients with confirmed H1N1 pneumonia and on mechanical ventilator support, a group treated with corticosteroids and 2 mg/day of sirolimus for 14 days (N=19) showed significantly better clinical outcomes compared with the group treated with corticosteroids only, including shorter median duration of ventilator used. Delayed oseltamivir plus sirolimus treatment in pH1N1-infected mouse model further suggested a significant association between the sirolimus treatment and improved outcomes. At least one in silico study identified sirolimus as one of the 16 potential candidates for treating COVID-19 patients based on data from other human coronavirus infections using network-based drug repurposing model.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamune
oral dose of 6 mg on day1 followed by 2 mg daily for 9 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 20 patients will receive sirolimus ( oral dose of 6 mg on day 1 followed by 2 mg daily for 9 days) plus national standard of care therapy against COVID 19 Receives: Drug: Sirolimus |
| Group B | No intervention | 20 patients will receive only national standard of care therapy against COVID 19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical recovery
The duration from start of treatment to normalization of pyrexia, respiratory rate ,O2 saturation and relief of cough that is maintained for at least 72 hours.
Measured: 14-28 days
Viral clearance
Two successive negative COVID-19 PCR analysis tests 48-72 hours apart
Measured: 14 days
Secondary outcomes (5)
radiological lung extension
Evaluate the lung extension of pneumonia at day 14
Measured: 14 days
drug adverse events
incidence and type of adverse events
Measured: 28 days
28 day mortality
number of deaths to total number of patients
Measured: 28 day
intensive care unit (ICU) admission rate
deteriorated patients who need admission to intensive care unit
Measured: 28 days
Duration of hospital stay
duration from hospitalization to discharge
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start15 Aug 2020
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blinded randomized clinical trial in which participants will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- Mohamed Mamdouh Elsayed, MD, Principal investigator, lecturerAyman I Baess, MD, Study chair, Associate professorHeba M El weshahi, MD, Study chair, professorNermine H Zakaria, MD, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461340
- Sponsor's protocol ID
- sirolimus in COVID 19
- Status last verified
- Sep 2020
- First submitted
- 4 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.
PubMed 31986261Singhal T. A Review of Coronavirus Disease-2019 (COVID-19). Indian J Pediatr. 2020 Apr;87(4):281-286. doi: 10.1007/s12098-020-03263-6. Epub 2020 Mar 13.
PubMed 32166607Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
PubMed 32125452Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.
PubMed 32217835Sun D, Li H, Lu XX, Xiao H, Ren J, Zhang FR, Liu ZS. Clinical features of severe pediatric patients with coronavirus disease 2019 in Wuhan: a single center's observational study. World J Pediatr. 2020 Jun;16(3):251-259. doi: 10.1007/s12519-020-00354-4. Epub 2020 Mar 19.
PubMed 32193831Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.
PubMed 28466096Lu H. Drug treatment options for the 2019-new coronavirus (2019-nCoV). Biosci Trends. 2020 Mar 16;14(1):69-71. doi: 10.5582/bst.2020.01020. Epub 2020 Jan 28.
PubMed 31996494Seto B. Rapamycin and mTOR: a serendipitous discovery and implications for breast cancer. Clin Transl Med. 2012 Nov 15;1(1):29. doi: 10.1186/2001-1326-1-29.
PubMed 23369283Kindrachuk J, Ork B, Hart BJ, Mazur S, Holbrook MR, Frieman MB, Traynor D, Johnson RF, Dyall J, Kuhn JH, Olinger GG, Hensley LE, Jahrling PB. Antiviral potential of ERK/MAPK and PI3K/AKT/mTOR signaling modulation for Middle East respiratory syndrome coronavirus infection as identified by temporal kinome analysis. Antimicrob Agents Chemother. 2015 Feb;59(2):1088-99. doi: 10.1128/AAC.03659-14. Epub 2014 Dec 8.
PubMed 25487801Wang CH, Chung FT, Lin SM, Huang SY, Chou CL, Lee KY, Lin TY, Kuo HP. Adjuvant treatment with a mammalian target of rapamycin inhibitor, sirolimus, and steroids improves outcomes in patients with severe H1N1 pneumonia and acute respiratory failure. Crit Care Med. 2014 Feb;42(2):313-21. doi: 10.1097/CCM.0b013e3182a2727d.
PubMed 24105455Jia X, Liu B, Bao L, Lv Q, Li F, Li H, An Y, Zhang X, Cao B, Wang C. Delayed oseltamivir plus sirolimus treatment attenuates H1N1 virus-induced severe lung injury correlated with repressed NLRP3 inflammasome activation and inflammatory cell infiltration. PLoS Pathog. 2018 Nov 13;14(11):e1007428. doi: 10.1371/journal.ppat.1007428. eCollection 2018 Nov.
PubMed 30422993Zhou Y, Hou Y, Shen J, Huang Y, Martin W, Cheng F. Network-based drug repurposing for novel coronavirus 2019-nCoV/SARS-CoV-2. Cell Discov. 2020 Mar 16;6:14. doi: 10.1038/s41421-020-0153-3. eCollection 2020.
PubMed 32194980
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sirolimus for Treating COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04461340
- Acronym / sponsor ID
- sirolimus in COVID 19
- Conditions
- COVID 19
- Keywords
- sirolimus, COVID 19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 8 Jul 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.
This research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection
Detailed description
In early December 2019, several pneumonia cases of unknown origin were observed in Wuhan (China). A novel enveloped RNA β coronavirus was isolated and named severe acute respiratory syndrome coronavirus 2 (SARSCoV- 2). The new virus rapidly spread across China and worldwide. On March 11th 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) a pandemic. As of 1July 2020, COVID-19 has been confirmed in 10,357,662 individuals globally with deaths reaching 508,055 with a morality of 5.37%. Egypt has 68,311 confirmed cases and 2935 deaths.
The virus mainly spreads through respiratory droplets from infected patients. The clinical spectrum of COVID-19 infection ranges from asymptomatic forms to severe pneumonia requiring hospitalization and isolation in critical care units with the need of mechanical ventilation due to acute respiratory distress syndrome (ARDS). Main symptoms include fever, fatigue and dry cough. Common laboratory findings include lymphopenia and elevated lactate dehydrogenase levels. Platelet count is usually normal or mildly decreased. C reactive protein (CRP) and erythrocyte sedimentation rate (ESR) are usually increased while procalcitonin levels are normal and elevation of procalcitonin usually indicates secondary bacterial infection. Ferritin, D-dimer, and creatine kinase elevation is associated with severe disease. Chest computed tomographic scans show a typical pattern of bilateral patchy shadows or ground glass opacity.
Severe COVID-19 conditions are usually due to an aggressive inflammatory response known as "cytokine storm" that is characterized by the release of a large amount of pro-inflammatory cytokines. Lung injury, multiorgan failure, and unfavorable prognosis of severe COVID-19 infection have been attributed mainly to the cytokine storm state.
Many proinflammatory cytokines elevate in COVID-19 patients including interleukin (IL)-1, IL-6, IL-8, IL-10, tumor necrosis factor (TNF)-α and interferon( IFN)-Ȣ stimulating immune cells to invade sites of infection causing endothelial dysfunction, vascular damage, alveolar damage and ARDS. Cytokine storm has been reported in several viral infections including influenza H5N1 virus, influenza H1N1 virus, and the two coronaviruses highly related to COVID-19; "SARS-CoV" and "MERSCoV".
Currently, there is no vaccine and/or specific therapeutic drugs targeting the SARS-CoV-2. Hence, it remains a major challenge to decide what potential therapeutic regimens to prevent and treat severe COVID-19 infections. Effective vaccines are essential to combat against the extremely contagious SARS-CoV-2. Until we have specific vaccines or therapeutic drugs targeting SARS-CoV-2, "repurposed" drugs have been used to treat COVID-19 patients. At present, treatment of SARS-CoV-2 infection are mainly repurposing the available therapeutic drugs and based on symptomatic conditions. Considering ARDS, followed by secondary infections, antibiotics, antiviral therapy, systemic corticosteroids, and anti-inflammatory drugs (including anti-arthritis drugs) are often used in the treatment regimens. Neuraminidase inhibitors, RNA synthesis inhibitors, convalescent plasma, and traditional herbal medicines have also been utilized in the treatment of COVID 19. Nevertheless, the efficacy of these treatment regimens remains to be verified by appropriately designed clinical trials. Sirolimus, also known as rapamycin, is an immunosuppressant that is used to prevent organ transplant rejection by inhibiting mammalian target of rapamycin (mTOR) kinase. mTOR plays a key role in viral replication. In an in vitro experiment, sirolimus has been shown to affect PI3K/AKT/mTOR pathway which inhibited MERS-CoV activity. Studies of patients hospitalized with influenza can further shed light on the antiviral effect of sirolimus. In a randomized clinical trial conducted on 38 patients with confirmed H1N1 pneumonia and on mechanical ventilator support, a group treated with corticosteroids and 2 mg/day of sirolimus for 14 days (N=19) showed significantly better clinical outcomes compared with the group treated with corticosteroids only, including shorter median duration of ventilator used. Delayed oseltamivir plus sirolimus treatment in pH1N1-infected mouse model further suggested a significant association between the sirolimus treatment and improved outcomes. At least one in silico study identified sirolimus as one of the 16 potential candidates for treating COVID-19 patients based on data from other human coronavirus infections using network-based drug repurposing model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blinded randomized clinical trial in which participants will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Sirolimus20 patients will receive sirolimus ( oral dose of 6 mg on day 1 followed by 2 mg daily for 9 days) plus national standard of care therapy against COVID 19 |
| Group B | No intervention | –20 patients will receive only national standard of care therapy against COVID 19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (˃18 years) COVID-19 positive patients (confirmed by PCR).
- Moderate infection ( pneumonia ± leucopenia or lymphopenia ).
Key exclusion criteria (11 listed)
- Severe or life threatening COVID infection: Severe disease is defined as: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours. Life threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure .
- Pregnant or lactating females.
- Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.
- Allergy or hypersensitivity to sirolimus.
- Taking immunosuppressive drugs.
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 |
|---|---|---|
| SirolimusAlso: Rapamuneoral dose of 6 mg on day1 followed by 2 mg daily for 9 days | Drug | Group A |
Primary outcome
Time to clinical recovery
Time frame: 14-28 days
The duration from start of treatment to normalization of pyrexia, respiratory rate ,O2 saturation and relief of cough that is maintained for at least 72 hours.
Viral clearance
Time frame: 14 days
Two successive negative COVID-19 PCR analysis tests 48-72 hours apart
5 secondary outcomes
radiological lung extension
Time frame: 14 days
drug adverse events
Time frame: 28 days
28 day mortality
Time frame: 28 day
intensive care unit (ICU) admission rate
Time frame: 28 days
Duration of hospital stay
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 31986261Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.
- Background: PubMed 32166607Singhal T. A Review of Coronavirus Disease-2019 (COVID-19). Indian J Pediatr. 2020 Apr;87(4):281-286. doi: 10.1007/s12098-020-03263-6. Epub 2020 Mar 13.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 32125452Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
- Background: PubMed 32217835Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.
- Background: PubMed 32193831Sun D, Li H, Lu XX, Xiao H, Ren J, Zhang FR, Liu ZS. Clinical features of severe pediatric patients with coronavirus disease 2019 in Wuhan: a single center's observational study. World J Pediatr. 2020 Jun;16(3):251-259. doi: 10.1007/s12519-020-00354-4. Epub 2020 Mar 19.
- Background: PubMed 28466096Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.
- Background: PubMed 31996494Lu H. Drug treatment options for the 2019-new coronavirus (2019-nCoV). Biosci Trends. 2020 Mar 16;14(1):69-71. doi: 10.5582/bst.2020.01020. Epub 2020 Jan 28.
- Background: PubMed 23369283Seto B. Rapamycin and mTOR: a serendipitous discovery and implications for breast cancer. Clin Transl Med. 2012 Nov 15;1(1):29. doi: 10.1186/2001-1326-1-29.
- Background: PubMed 25487801Kindrachuk J, Ork B, Hart BJ, Mazur S, Holbrook MR, Frieman MB, Traynor D, Johnson RF, Dyall J, Kuhn JH, Olinger GG, Hensley LE, Jahrling PB. Antiviral potential of ERK/MAPK and PI3K/AKT/mTOR signaling modulation for Middle East respiratory syndrome coronavirus infection as identified by temporal kinome analysis. Antimicrob Agents Chemother. 2015 Feb;59(2):1088-99. doi: 10.1128/AAC.03659-14. Epub 2014 Dec 8.
- Background: PubMed 24105455Wang CH, Chung FT, Lin SM, Huang SY, Chou CL, Lee KY, Lin TY, Kuo HP. Adjuvant treatment with a mammalian target of rapamycin inhibitor, sirolimus, and steroids improves outcomes in patients with severe H1N1 pneumonia and acute respiratory failure. Crit Care Med. 2014 Feb;42(2):313-21. doi: 10.1097/CCM.0b013e3182a2727d.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Mamdouh Elsayed, MD principal investigator
lecturer
Ayman I Baess, MD study chair
Associate professor
Heba M El weshahi, MD study chair
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus in people with COVID 19, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 9 Sep 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mamdouh Elsayed, MD (00201068055103, dr_mohamedmamdouh87@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical recovery (time frame: 14-28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04461340, which also lists 14 linked publications.
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 9 Sep 2020.