COVID-19COVID19_VaxSOTNCT05116748

COVID19 Vaccine in SOT Adult Recipients

An observational study of COVID-19 and Vaccine Adverse Reaction, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Background: ISHLT and AASLD guidelines recommend SARS-CoV2 vaccination in all individuals undergoing lung and liver transplantation, but there are currently scarce data on the safety and efficacy of these vaccines in this population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19, Vaccine Adverse Reaction, Vaccine Response Impaired
What is being tested?: COVID19 mRNA vaccine
Type of treatment: Vaccines
How many people: 364 participants
Where: 1 siteItaly
Study dates: 1 Oct 2021to 31 Dec 2023
Phase: Observational
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

Study population: Lung and liver transplant recipients

Who may be able to join

Age > 18 years
Patient's written informed consent

Who cannot join

Lung transplant being performed in the previous 6 months
Liver transplant being performed in the previous 3 months

Trial locations and contacts

1 site in 1 country.

Italy1 site

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122

Other trials in Italy

About this study

Official title: Safety and Immunogenicity of the SARS-CoV2 Vaccine in Solid Organ Transplantation (Lung and / or Liver) Adult Recipients

Primary outcome: safety and reactogenicity Secondary outcomes: immunogenicity and prevention of COVID19

Visits and timepoints:

T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status
Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination
T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity
Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity

Read the detailed description

Several studies indicate that solid organ transplant recipients are at increased risk of severe SARS-CoV2 disease (COVID19) and increased mortality from it (Pereira MR, AmJT 2020; Fernandez-Ruiz M, AmJT 2020; Kates OS, ClinInfectDis 2020).

Both ISHLT (International Society of Heart and Lung Transplantation) and AASLD (American Association for the Study of Liver Disease) guidelines recommend vaccination of all individuals undergoing lung and liver transplantation, starting from 3/6 months after transplantation.

In Italy, the Ministry of Health and the Italian Medicines Agency (AIFA) have established that immunosuppressed subjects following organ transplantation are worthy of vaccination with mRNA vaccines, since the latter are currently those with the greatest efficacy demonstrated among those approved in this country.

Within the Institution where this study will be conducted, patients undergoing lung and liver transplantation will be vaccinated, according to priority levels dictated by existing co-morbidities and by the time elapsed since transplantation, with the COMIRNATY mRNA vaccine (BNT162b2) administered according to the vaccination schedule of 2 doses at a distance of 21 days from each other or with the MODERNA vaccine (mRNA-1273) administered according to a vaccination schedule of 2 doses at a distance of 28 days from each other.

At present, no definitive data are available on the efficacy and the immunogenicity of anti-SARS-CoV-2 vaccines in solid organ transplant recipients, although the initial findings are reassuring. mRNA vaccines appear to be safe in the transplant population, and have not raised any concern at present about the possible onset of rejection or other serious adverse events in the first period after their administration (Boyarsky BJ, Transplantation 2021).

The primary objective of this study is to evaluate the safety and reactogenicity of antiSARS-CoV2 mRNA vaccines in SOT recipients.

Secondary outcomes include immunogenicity and efficacy (see Outcome paragraph for details).

Visits and timepoints:

T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status
Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination
T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity
Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity

Conditions: COVID-19, Vaccine Adverse Reaction, Vaccine Response Impaired, Vaccine Reaction, Lung Transplant; Complications, Liver Transplant; Complications
Being tested: COVID19 mRNA vaccine
Keywords: COVID19, Vaccination, Vaccine, Transplant, Solid organ transplant, Lung transplant, Liver transplant
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COVID19 mRNA vaccineBiological
Administration of COVID19 mRNA vaccine

Study groups in NCT05116748
Study group	Role	What they receive
LuTx recipients		Lung Transplant recipients Receives: Biological: COVID19 mRNA vaccine
OLT recipients		Orthotopic Liver Transplant recipients Receives: Biological: COVID19 mRNA vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and reactogenicity
Primary endpoints:
- Incidence of systemic and local adverse events (and their degree) in the subsequent 7 days after each vaccine administration in this population
- Incidence of unusual adverse events (and their degree) in the subsequent 28 days after each vaccine administration in this population
- Incidence of serious adverse events (SAEs) and sentinel events (NOCMCs, new onset chronic medical conditions, and MAAEs, medically-attended adverse events) over a 1-year follow-up period after administration of the first vaccine dose in this population
Measured: 365 days

Secondary outcomes (5)

Immunogenicity - antibody response, using ImmunoAssay in ECLIA for the quantitative detection of anti-protein S1 (spike) antibodies (including IgG)
- Geometric mean titer (GMT) of SARS-CoV2 anti-protein S1 total Ig (spike) antibody titers (GMT) at each timepoint
- Percentage of individuals experiencing seroconversion at each timepoint
- Increase of antibody titers (GMFR, geometric mean fold rise) from T0
Measured: 365 days
Immunogenicity - Tcell response, using IGRA interferon-γ ELISpot, performed 60 days after the administration of the first vaccine dose
- Evaluation of the IFN-γ ELISpot-mediated T-cell response for different stimuli (peptides of proteins S1, S2, N, M, E and mix of structural proteins), measured with the following unit of measurement, i.e. IFN -γ spots / 250,000 PBMC (peripheral blood mononuclear cell) for each stimulus, 60 days after the first vaccine dose
Measured: 60 days
Prevention of COVID19
- Incidence of SARS-CoV2 infection, diagnosed with positivity of nasopharyngeal swab (SARS-CoV2 RNA search with RT-Real time PCR method)
Measured: 365 days
Prevention of severe COVID19
To evaluate the actual prevention of severe forms of SARS-CoV2 infection in this population
- Incidence of severe forms of SARS-CoV2 infections, defined as requiring hospitalization of the patient and / or conditioning pneumonia / respiratory failure / sepsis / septic shock / ARDS
Measured: 365 days
Immunogenicity and immunosuppression level
To compare the obtained (both antibody and T cell mediated) immunogenicity with the immunosuppression levels
Measured: 365 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202131 Dec 2023

First posted11 Nov 2021
Study start1 Oct 2021
Primary completion30 Dec 2022
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)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 Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 364 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05116748
Sponsor's protocol ID: COVID19_VaxSOT
Acronym: COVID19_VaxSOT
Status last verified: Apr 2024
First submitted: 28 Sep 2021
Last updated: 2 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.
PubMed 33378609
Blumenthal KG, Robinson LB, Camargo CA Jr, Shenoy ES, Banerji A, Landman AB, Wickner P. Acute Allergic Reactions to mRNA COVID-19 Vaccines. JAMA. 2021 Apr 20;325(15):1562-1565. doi: 10.1001/jama.2021.3976.
PubMed 33683290
Boyarsky BJ, Ou MT, Greenberg RS, Teles AT, Werbel WA, Avery RK, Massie AB, Segev DL, Garonzik-Wang JM. Safety of the First Dose of SARS-CoV-2 Vaccination in Solid Organ Transplant Recipients. Transplantation. 2021 May 1;105(5):e56-e57. doi: 10.1097/TP.0000000000003654. No abstract available.
PubMed 33560728
Boyarsky BJ, Werbel WA, Avery RK, Tobian AAR, Massie AB, Segev DL, Garonzik-Wang JM. Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients. JAMA. 2021 May 4;325(17):1784-1786. doi: 10.1001/jama.2021.4385.
PubMed 33720292
Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, Hernan MA, Lipsitch M, Reis B, Balicer RD. BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. N Engl J Med. 2021 Apr 15;384(15):1412-1423. doi: 10.1056/NEJMoa2101765. Epub 2021 Feb 24.
PubMed 33626250
Fernandez-Ruiz M, Andres A, Loinaz C, Delgado JF, Lopez-Medrano F, San Juan R, Gonzalez E, Polanco N, Folgueira MD, Lalueza A, Lumbreras C, Aguado JM. COVID-19 in solid organ transplant recipients: A single-center case series from Spain. Am J Transplant. 2020 Jul;20(7):1849-1858. doi: 10.1111/ajt.15929. Epub 2020 May 10.
PubMed 32301155
Fung M, Chiu CY, DeVoe C, Doernberg SB, Schwartz BS, Langelier C, Henrich TJ, Yokoe D, Davis J, Hays SR, Chandran S, Kukreja J, Ng D, Prostko J, Taylor R, Reyes K, Bainbridge E, Bond A, Chin-Hong P, Babik JM. Clinical outcomes and serologic response in solid organ transplant recipients with COVID-19: A case series from the United States. Am J Transplant. 2020 Nov;20(11):3225-3233. doi: 10.1111/ajt.16079. Epub 2020 Jul 17.
PubMed 32476258
Grasselli G, Greco M, Zanella A, Albano G, Antonelli M, Bellani G, Bonanomi E, Cabrini L, Carlesso E, Castelli G, Cattaneo S, Cereda D, Colombo S, Coluccello A, Crescini G, Forastieri Molinari A, Foti G, Fumagalli R, Iotti GA, Langer T, Latronico N, Lorini FL, Mojoli F, Natalini G, Pessina CM, Ranieri VM, Rech R, Scudeller L, Rosano A, Storti E, Thompson BT, Tirani M, Villani PG, Pesenti A, Cecconi M; COVID-19 Lombardy ICU Network. Risk Factors Associated With Mortality Among Patients With COVID-19 in Intensive Care Units in Lombardy, Italy. JAMA Intern Med. 2020 Oct 1;180(10):1345-1355. doi: 10.1001/jamainternmed.2020.3539.
PubMed 32667669
Kates OS, Haydel BM, Florman SS, Rana MM, Chaudhry ZS, Ramesh MS, Safa K, Kotton CN, Blumberg EA, Besharatian BD, Tanna SD, Ison MG, Malinis M, Azar MM, Rakita RM, Morilla JA, Majeed A, Sait AS, Spaggiari M, Hemmige V, Mehta SA, Neumann H, Badami A, Goldman JD, Lala A, Hemmersbach-Miller M, McCort ME, Bajrovic V, Ortiz-Bautista C, Friedman-Moraco R, Sehgal S, Lease ED, Fisher CE, Limaye AP; UW COVID-19 SOT Study Team. Coronavirus Disease 2019 in Solid Organ Transplant: A Multicenter Cohort Study. Clin Infect Dis. 2021 Dec 6;73(11):e4090-e4099. doi: 10.1093/cid/ciaa1097.
PubMed 32766815
Long L, Zeng X, Zhang X, Xiao W, Guo E, Zhan W, Yang X, Li C, Wu C, Xu T, Zhan C, Chen Y, Jiang M, Zhong N, Lai K. Short-term outcomes of COVID-19 and risk factors for progression. Eur Respir J. 2020 May 27;55(5):2000990. doi: 10.1183/13993003.00990-2020. Print 2020 May.
PubMed 32312863
Morlacchi LC, Rossetti V, Gigli L, Amati F, Rosso L, Aliberti S, Nosotti M, Blasi F. COVID-19 in lung transplant recipients: A case series from Milan, Italy. Transpl Infect Dis. 2020 Dec;22(6):e13356. doi: 10.1111/tid.13356. Epub 2020 Jun 26.
PubMed 32510771
Pereira MR, Mohan S, Cohen DJ, Husain SA, Dube GK, Ratner LE, Arcasoy S, Aversa MM, Benvenuto LJ, Dadhania DM, Kapur S, Dove LM, Brown RS Jr, Rosenblatt RE, Samstein B, Uriel N, Farr MA, Satlin M, Small CB, Walsh TJ, Kodiyanplakkal RP, Miko BA, Aaron JG, Tsapepas DS, Emond JC, Verna EC. COVID-19 in solid organ transplant recipients: Initial report from the US epicenter. Am J Transplant. 2020 Jul;20(7):1800-1808. doi: 10.1111/ajt.15941. Epub 2020 May 10.
PubMed 32330343
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.
PubMed 33301246
Sette A, Crotty S. Adaptive immunity to SARS-CoV-2 and COVID-19. Cell. 2021 Feb 18;184(4):861-880. doi: 10.1016/j.cell.2021.01.007. Epub 2021 Jan 12.
PubMed 33497610
Shimabukuro TT, Cole M, Su JR. Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US-December 14, 2020-January 18, 2021. JAMA. 2021 Mar 16;325(11):1101-1102. doi: 10.1001/jama.2021.1967. No abstract available.
PubMed 33576785

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of the SARS-CoV2 Vaccine in Solid Organ Transplantation (Lung and / or Liver) Adult Recipients
ClinicalTrials.gov ID: NCT05116748
Acronym / sponsor ID: COVID19_VaxSOT / COVID19_VaxSOT
Conditions: COVID-19, Vaccine Adverse Reaction, Vaccine Response Impaired, Vaccine Reaction, Lung Transplant; Complications, Liver Transplant; Complications
Keywords: COVID19, Vaccination, Vaccine, Transplant, Solid organ transplant, Lung transplant, Liver transplant
Study type: Observational
Recruitment status: Completed
Enrolment: 364 participants (actual)
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
Study start: 1 Oct 2021 (actual)
Primary completion: 30 Dec 2022 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 11 Nov 2021 (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.

Primary outcome: safety and reactogenicity Secondary outcomes: immunogenicity and prevention of COVID19

Visits and timepoints:

T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status
Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination
T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity
Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity

Detailed description

The primary objective of this study is to evaluate the safety and reactogenicity of antiSARS-CoV2 mRNA vaccines in SOT recipients.

Secondary outcomes include immunogenicity and efficacy (see Outcome paragraph for details).

Visits and timepoints:

T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status
Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination
T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity
Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
LuTx recipients	–	Biological: COVID19 mRNA vaccineLung Transplant recipients
OLT recipients	–	Biological: COVID19 mRNA vaccineOrthotopic Liver Transplant recipients

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Lung and liver transplant recipients

Key inclusion criteria (2 listed)

Age > 18 years
Patient's written informed consent

Key exclusion criteria (2 listed)

Lung transplant being performed in the previous 6 months
Liver transplant being performed in the previous 3 months

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
COVID19 mRNA vaccineAdministration of COVID19 mRNA vaccine	Biological	LuTx recipients, OLT recipients

Primary outcome

Safety and reactogenicity
Time frame: 365 days
Primary endpoints: * Incidence of systemic and local adverse events (and their degree) in the subsequent 7 days after each vaccine administration in this population * Incidence of unusual adverse events (and their degree) in the subsequent 28 days after each vaccine administration in this population * Incidence of serious adverse events (SAEs) and sentinel events (NOCMCs, new onset chronic medical conditions, and MAAEs, medically-attended adverse events) over a 1-year follow-up period after administration of the first vaccine dose in this population

5 secondary outcomes

Immunogenicity - antibody response, using ImmunoAssay in ECLIA for the quantitative detection of anti-protein S1 (spike) antibodies (including IgG)
Time frame: 365 days
Immunogenicity - Tcell response, using IGRA interferon-γ ELISpot, performed 60 days after the administration of the first vaccine dose
Time frame: 60 days
Prevention of COVID19
Time frame: 365 days
Prevention of severe COVID19
Time frame: 365 days
Immunogenicity and immunosuppression level
Time frame: 365 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 2 Apr 2024.
Background: PubMed 33378609Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.
Background: PubMed 33683290Blumenthal KG, Robinson LB, Camargo CA Jr, Shenoy ES, Banerji A, Landman AB, Wickner P. Acute Allergic Reactions to mRNA COVID-19 Vaccines. JAMA. 2021 Apr 20;325(15):1562-1565. doi: 10.1001/jama.2021.3976.
Background: PubMed 33560728Boyarsky BJ, Ou MT, Greenberg RS, Teles AT, Werbel WA, Avery RK, Massie AB, Segev DL, Garonzik-Wang JM. Safety of the First Dose of SARS-CoV-2 Vaccination in Solid Organ Transplant Recipients. Transplantation. 2021 May 1;105(5):e56-e57. doi: 10.1097/TP.0000000000003654. No abstract available.
Background: PubMed 33720292Boyarsky BJ, Werbel WA, Avery RK, Tobian AAR, Massie AB, Segev DL, Garonzik-Wang JM. Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients. JAMA. 2021 May 4;325(17):1784-1786. doi: 10.1001/jama.2021.4385.
Background: PubMed 33626250Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, Hernan MA, Lipsitch M, Reis B, Balicer RD. BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. N Engl J Med. 2021 Apr 15;384(15):1412-1423. doi: 10.1056/NEJMoa2101765. Epub 2021 Feb 24.
Background: PubMed 32301155Fernandez-Ruiz M, Andres A, Loinaz C, Delgado JF, Lopez-Medrano F, San Juan R, Gonzalez E, Polanco N, Folgueira MD, Lalueza A, Lumbreras C, Aguado JM. COVID-19 in solid organ transplant recipients: A single-center case series from Spain. Am J Transplant. 2020 Jul;20(7):1849-1858. doi: 10.1111/ajt.15929. Epub 2020 May 10.
Background: PubMed 32476258Fung M, Chiu CY, DeVoe C, Doernberg SB, Schwartz BS, Langelier C, Henrich TJ, Yokoe D, Davis J, Hays SR, Chandran S, Kukreja J, Ng D, Prostko J, Taylor R, Reyes K, Bainbridge E, Bond A, Chin-Hong P, Babik JM. Clinical outcomes and serologic response in solid organ transplant recipients with COVID-19: A case series from the United States. Am J Transplant. 2020 Nov;20(11):3225-3233. doi: 10.1111/ajt.16079. Epub 2020 Jul 17.
Background: PubMed 32667669Grasselli G, Greco M, Zanella A, Albano G, Antonelli M, Bellani G, Bonanomi E, Cabrini L, Carlesso E, Castelli G, Cattaneo S, Cereda D, Colombo S, Coluccello A, Crescini G, Forastieri Molinari A, Foti G, Fumagalli R, Iotti GA, Langer T, Latronico N, Lorini FL, Mojoli F, Natalini G, Pessina CM, Ranieri VM, Rech R, Scudeller L, Rosano A, Storti E, Thompson BT, Tirani M, Villani PG, Pesenti A, Cecconi M; COVID-19 Lombardy ICU Network. Risk Factors Associated With Mortality Among Patients With COVID-19 in Intensive Care Units in Lombardy, Italy. JAMA Intern Med. 2020 Oct 1;180(10):1345-1355. doi: 10.1001/jamainternmed.2020.3539.
Background: PubMed 32766815Kates OS, Haydel BM, Florman SS, Rana MM, Chaudhry ZS, Ramesh MS, Safa K, Kotton CN, Blumberg EA, Besharatian BD, Tanna SD, Ison MG, Malinis M, Azar MM, Rakita RM, Morilla JA, Majeed A, Sait AS, Spaggiari M, Hemmige V, Mehta SA, Neumann H, Badami A, Goldman JD, Lala A, Hemmersbach-Miller M, McCort ME, Bajrovic V, Ortiz-Bautista C, Friedman-Moraco R, Sehgal S, Lease ED, Fisher CE, Limaye AP; UW COVID-19 SOT Study Team. Coronavirus Disease 2019 in Solid Organ Transplant: A Multicenter Cohort Study. Clin Infect Dis. 2021 Dec 6;73(11):e4090-e4099. doi: 10.1093/cid/ciaa1097.
Background: PubMed 32312863Long L, Zeng X, Zhang X, Xiao W, Guo E, Zhan W, Yang X, Li C, Wu C, Xu T, Zhan C, Chen Y, Jiang M, Zhong N, Lai K. Short-term outcomes of COVID-19 and risk factors for progression. Eur Respir J. 2020 May 27;55(5):2000990. doi: 10.1183/13993003.00990-2020. Print 2020 May.
Background: PubMed 32510771Morlacchi LC, Rossetti V, Gigli L, Amati F, Rosso L, Aliberti S, Nosotti M, Blasi F. COVID-19 in lung transplant recipients: A case series from Milan, Italy. Transpl Infect Dis. 2020 Dec;22(6):e13356. doi: 10.1111/tid.13356. Epub 2020 Jun 26.
Background: PubMed 32330343Pereira MR, Mohan S, Cohen DJ, Husain SA, Dube GK, Ratner LE, Arcasoy S, Aversa MM, Benvenuto LJ, Dadhania DM, Kapur S, Dove LM, Brown RS Jr, Rosenblatt RE, Samstein B, Uriel N, Farr MA, Satlin M, Small CB, Walsh TJ, Kodiyanplakkal RP, Miko BA, Aaron JG, Tsapepas DS, Emond JC, Verna EC. COVID-19 in solid organ transplant recipients: Initial report from the US epicenter. Am J Transplant. 2020 Jul;20(7):1800-1808. doi: 10.1111/ajt.15941. Epub 2020 May 10.
Agenzia Italiana del Farmaco.Link provided by the sponsor.
Ministero della Salute del Governo ItalianoLink provided by the sponsor.
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0Link provided by the sponsor.
World Health OrganizationLink provided by the sponsor.
NY Times vaccine trackerLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Letizia Corinna Morlacchi, MD principal investigator

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Vaccine Adverse Reaction, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

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 2 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 2 Apr 2024. 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 Italy. 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?

Safety and reactogenicity (time frame: 365 days). 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 NCT05116748, which also lists 17 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 2 Apr 2024.