Weekly Update

Weekly Update: July 23 to August 05, 2022.

The analysis is updated every two weeks.

New Studies with results available

8 new RCTs with results are available on our website: see here for vaccine et here for treatment

Bouadma L, JAMA Intern Med, 2022 High-Dose Dexamethasone and Oxygen Support Strategies in Intensive Care Unit Patients With Severe COVID-19 Acute Hypoxemic Respiratory Failure: The COVIDICUS Randomized Clinical Trial.
Dastenae ZH, Int J Infect Dis, 2022 Comparison of the effect of intravenous dexamethasone and methylprednisolone on the treatment of hospitalized patients with COVID-19: A randomized clinical trial.
Hui AH, SSRN, 2022 Immunogenicity and Safety of BNT162b2 mRNA Vaccine in Chinese Adults: A Randomized Clinical Trial
Khobragade A, Lancet, 2022 Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in India.
Masuda T, Vaccine, 2022 Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial.
Rahman SMA, Clin Infect Pract, 2022 Safety and Efficacy of Favipiravir for the management of COVID-19 Patients: A Randomized Control Trial.
Rojas M, BMC Infect Dis, 2022 Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study.
Self WH, Chest, 2022 Neutralizing COVID-19 Convalescent Plasma in Adults Hospitalized with COVID-19: A Blinded Randomized Placebo-Controlled Trial.

Studies pending data extraction

24 new pharmacological and/or preventive RCTs:

Arruda E A G, medrxiv, 2021 Clinical Trial of Efficacy and Toxicity of Disoproxil Tenofovir Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections
Bozorgmehr R, Arch Acad Emerg Med, 2022 Effect of Sofosbuvir on Length of Hospital Stay in Moderate COVID-19 Cases; a Randomized Controlled Trial.
Chung R, Unpublished, 2022 Pegylated Interferon Lambda Treatment for COVID-19
Elmekaty EZ, medRxiv, 2022 Efficacy of Anakinra in the Management of Patients with COVID-19 Infection: A Randomized Clinical Trial
FibroGen, Unpublished, 2022 Phase 2 Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Patients With Acute COVID-19 Disease
Gusdon AM, Sci Transl Med, 2022 Dendrimer nanotherapy for severe COVID-19 attenuates inflammation and neurological injury markers and improves outcomes in a phase2a clinical trial.
Holland T, Lancet Respir Med, 2022 Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial.
Hooper AT, medrxiv, 2022 Casirivimab and Imdevimab Treatment in Seropositive, Hospitalized COVID-19 Patients With Non-neutralizing or Borderline Neutralizing Antibodies
Huang DT, JAMA Netw Open, 222 Effectiveness of Casirivimab-Imdevimab and Sotrovimab During a SARS-CoV-2 Delta Variant Surge: A Cohort Study and Randomized Comparative Effectiveness Trial.
Johnson MG, Ann Intern Med, 2022 Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial.
Khoo SH, medRxiv, 2022 A Randomised -Controlled Phase 2 trial of Molnupiravir in Unvaccinated and Vaccinated Individuals with Early SARS-CoV-2
McMahon JH, SSRN, 2022 Favipiravir in Early Symptomatic COVID-19, A Randomised Placebo-Controlled Trial
Medhat MA, Arab J Gastroenterol, 2022 Sofosbuvir/ledipasvir in combination or nitazoxanide alone are safe and efficient treatments for COVID-19 infection: A randomized controlled trial for repurposing antivirals.
Montejano R, Clin Infect Dis, 2022 Tenofovir Disoproxil Fumarate/Emtricitabine and Baricitinib for Patients at High Risk of Severe COVID-19: The PANCOVID Randomized Clinical Trial.
Naggie S, medRxiv, 2022 Inhaled Fluticasone for Outpatient Treatment of Covid-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial
NCT04590586, Unpublished, 2022 Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients
Sivapalasingam Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Pneumonia
Streinu-Cercel A, Open Forum Infect Dis, 2022 To Evaluate the Safety and Efficacy of CT-P59 in Patients With Mild to Moderate Syptoms of Severe Acute Respiratory Syndrome COVID-19
Tam AR, Clin Infect Dis, 2022 Early treatment of high-risk hospitalized COVID-19 patients with a combination of interferon beta-1b and remdesivir: a phase 2 open-label randomized controlled trial.
Terada J, EClinicalMedicine, 2022 Favipiravir, camostat, and ciclesonide combination therapy in patients with moderate COVID-19 pneumonia with/without oxygen therapy: An open-label, single-center phase 3 randomized clinical trial.
Tobback E, Int J Infect Dis, 2022 Efficacy and safety of camostat mesylate in early Covid-19 disease in an ambulatory setting: A randomized placebo-controlled phase II trial.
Wadhwa B, medRxiv, 2022 Phase 2 randomised placebo-controlled trial of spironolactone and dexamethasone versus dexamethasone in COVID-19 hospitalised patients in Delhi
Yakoot M, medRxiv, 2022 Clinical utility of repurposing a short course of hepatitis C drugs for COVID19. A randomized controlled study
Zou R, Front Pharm, 2022 Antiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial.

21 new vaccine RCTs under extraction:

Achiron A, J Neurol, 2022 Immune response to the third COVID-19 vaccine dose is related to lymphocyte count in multiple sclerosis patients treated with fingolimod.
Al Kaabi N, medRxiv, 2022 Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients: a randomized controlled phase 2 trial
Anderson E, Research Square, 2022 Safety and Immunogenicity of a Third Dose of SARS-CoV-2 mRNA Vaccine An Interim Analysis
Barrios L, , medRxiv, 2022 An Evaluation of the Safety and Immunogenicity of MVC-COV1901: Results of an interim analysis of a phase III, parallel group, randomized, double-blind, active-controlled study
Branche AR, medRxiv, 2022 SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses
Bruminhent J, Am J Transplant, 2022 An additional dose of viral vector COVID-19 vaccine and mRNA COVID-19 vaccine in kidney transplant recipients: a randomized controlled trial (CVIM 4 study).
Corominas J, medRxiv, 2022 Safety and immunogenicity of the protein-based PHH-IV compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority phase IIb trial.
Costa Clemens SA, medrxiv, 2022 Homologous and heterologous boosting of the ChAdOx1-S1-S COVID-19 vaccine with the SCB-2019 vaccine candidate: a randomized, observer-blinded, controlled, phase 2 study
El Sahly HM, J Infect Dis, 2022 Humoral Immunogenicity of the mRNA-1273 Vaccine in the Phase 3 COVE Trial.
Jin P, medrxiv, 2022 Heterologous CoronaVac plus Ad5-nCOV versus homologous CoronaVac vaccination among elderly: a phase 4, non-inferiority, randomized study
Kelliher MT, Arch Pathol Lab Med, 2022 Comparison of Symptoms and Antibody Response Following Administration of Moderna or Pfizer SARS-CoV-2 Vaccines.
LAUNAY O, medrxiv, 2022 Immunogenicity and Safety of Beta Adjuvanted Recombinant Booster Vaccine
Lazarus, SSRN, 2022 Pivotal Immune-Bridging Study of the Inactivated Whole-Virus COVID-19 Vaccine VLA2001: A Phase 3, Randomized Controlled Clinical Trial in Adults Using Adenoviral Vector Vaccine AZD1222 as a Comparator
Madhi SA, Lancet, 2022 Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A/2B trial.
Nantanee R, Vaccine, 2022 A Randomized Clinical Trial of a Fractional Low Dose of BNT162b2 Booster in Adults Following AZD1222.
Niyomnaitham S, Hum Vaccin Immunother, 2022 Immunogenicity and reactogenicity against the SARS-CoV-2 variants following heterologous primary series involving CoronaVac, ChAdox1 nCov-19 and BNT162b2 plus BNT162b2 booster vaccination: An open-label randomized study in healthy Thai adul
Rose W, SSRN, 2022 Immunogenicity and Safety of Homologous and Heterologous Booster Vaccination of ChAdOx1 nCoV-19 (COVISHIELDTM) and BBV152 (COVAXIN®) in Previous Recipients of COVISHIELDTM or COVAXIN®: A Phase 4, Participant and Observer Blinded, Randomis
Sung JC, Vaccines, 2022 Safety and Immunogenicity of Inactivated Bacillus subtilis Spores as a Heterologous Antibody Booster for COVID-19 Vaccines.
Tabarsi P, Immunology, 2022 Immunogenicity and Safety of SpikoGen®, an Adjuvanted Recombinant SARS-CoV-2 Spike Protein vaccine as a Homologous and Heterologous Booster Vaccination: A Randomized Placebo-Controlled Trial.
Zeng G, Lancet Infect Dis, 2021 Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials
Zhu F, Lancet Respir Med, 2022 Safety and immunogenicity of a live-attenuated influenza virus vector-based intranasal SARS-CoV-2 vaccine in adults: randomised, double-blind, placebo-controlled, phase 1 and 2 trials.

34 early phase vaccine trials where the vaccine dose and schedule have not yet been determined :

Abarca K, Vaccines, 2022 Safety and efficacy of two immunization schedules with an inactivated SARS-CoV-2 vaccine in adults. A randomized non-inferiority clinical trial.
Angkasekwinai N, Vaccine, 2021 Comparison of safety and immunogenicity of CoronaVac and ChAdOx1 against the SARS-CoV-2 circulating variants of concern (Alpha, Delta, Beta) in Thai healthcare workers
Anh DD, SSRN, 2022 Safety and Immunogenicity of an Egg-Based Inactivated Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: Interim Results of a Randomized, Placebo-Controlled, Phase 1/2 Trial in Vietnam
Butta N, SSRN, 2022 Effect of a COVID-19-Heterologous Vaccination Schedule on Haemostasis: A Subanalysis of the Phase 2, Multicentre, Randomised, Controlled CombiVacS Study
Cao Y, Sci China Life Sci, 2022 A third high dose of inactivated COVID-19 vaccine induces higher neutralizing antibodies in humans against the Delta and Omicron variants: a Randomized, Double-Blinded Clinical Trial.
Chen GL, Lancet microbe, 2022 Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial
Chen J, 2021 [A randomized controlled trial study of immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in different immunization schedules].
Chiuppesi F, Lancet Microbe, 2022 Safety and immunogenicity of a synthetic multiantigen modified vaccinia virus Ankara-based COVID-19 vaccine (COH04S1): an open-label and randomised, phase 1 trial.
Dang AD, medrxiv, 2022 Safety and Immunogenicity of An Egg-Based Inactivated Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: Interim Results of a Randomized, Placebo-Controlled, Phase 1/2 Trial in Vietnam
Follmann D, Ann Intern Med, 2022 Antinucleocapsid Antibodies After SARS-CoV-2 Infection in the Blinded Phase of the Randomized, Placebo-Controlled mRNA-1273 COVID-19 Vaccine Efficacy Clinical Trial.
Garcia-Perez J, eClinicalMedicine, 2022 Immunogenic dynamics and SARS-CoV-2 variant neutralisation of the heterologous ChAdOx1-S/BNT162b2 vaccination: Secondary analysis of the randomised CombiVacS study.
Iwata S, SSRN, 2022 Phase 1/2 Clinical Trial of COVID-19 Vaccine in Japanese Participants: A Report of Interim Findings
Launay O, EBioMedicine, 2022 Safety and immunogenicity of a measles-vectored SARS-CoV-2 vaccine candidate, V591 / TMV-083, in healthy adults: results of a randomized, placebo-controlled Phase I study.
Marchevsky NG, eBioMedicine, 2022 An exploratory analysis of the response to ChAdOx1 nCoV-19 (AZD1222) vaccine in males and females.
Mohraz M, BMJ Open, 2022 Safety and immunogenicity of an inactivated virus particle vaccine for SARS-CoV-2, BIV1-CovIran: findings from double-blind, randomised, placebo-controlled, phase I and II clinical trials among healthy adults.
Mohraz M, BMJ Open, 2022 Safety and immunogenicity of an inactivated virus particle vaccine for SARS-CoV-2, BIV1-CovIran: findings from double-blind, randomised, placebo-controlled, phase I and II clinical trials among healthy adults.
Orozco MN, medrxiv, 2022 Phase I study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B
Pajon R, Nat Med, 2022 Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial.
Pitisuttithum P, EClinicalMedicine, 2022 Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomised, placebo-controlled, phase 1 trial.
Pollock KM, eclinicalmedicine, 2022 Safety and immunogenicity of a self-amplifying RNA vaccine against COVID-19: COVAC1, a phase I, dose-ranging trial
Robbins JA, eBioMedicine, 2022 Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial.
Robbins JA, eBioMedicine, 2022 Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial.
Saez-Llorens X , SSRN, 2021 Safety and Immunogenicity of mRNA-LNP COVID-19 Vaccine CVnCoV in Latin American Adults; A Phase 2 Randomized Study
Song JY , medrxiv, 2022 Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: a phase 1/2, randomized, placebo-controlled, observer-blinded trial
Song JY, EClinicalMedicine, 2022 Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: A randomised, placebo-controlled, observer-blinded phase 1/2 trial.
Tabarsi P, CMI, 2022 Safety and immunogenicity of SpikoGen®, an advax-cpg55.2-adjuvanted sars-cov-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations.
Tanishima M, medRxiv, 2022 Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, KD-414, in healthy adult and elderly subjects: a randomized, double-blind, placebo-controlled, phase 1/2 clinical study in Japan
Tanishima M, medRxiv, 2022 Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, KD-414, in healthy adult and elderly subjects: a randomized, double-blind, placebo-controlled, phase 1/2 clinical study in Japan
Thuluva S, medRxiv, 2022 Selection of optimum formulation of RBD-based protein sub-unit covid19 vaccine (Corbevax) based on safety and immunogenicity in an open-label, randomized Phase-1 and 2 clinical studies
Vanhoutte F, EBioMedicine, 2022 Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial
Wang CY, J Clin Invest, 2022 A multitope SARS-COV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants.
Wynne C, medRxiv, 2022 The preliminary safety and immunogenicity results of a randomized, double-blind, placebo-controlled Phase I trial for a recombinant two-component subunit SARS-CoV-2 vaccine ReCOV
Xia S, Front Immunol, 2022 Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial.
Xia S, Front Immunol, 2022 Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial.

We stopped the living review for vaccine observational studies. Last search date Nov 03,2021. No more studies will be included after this date.

We have identified additional COVID-19 RCTs assessing:

  1. long COVID
  2. other interventions (dietary supplements or minerals and other technologies (e.g. cytokine adsorption)
  3. other COVID vaccines.

These interventions were not prioritized but they might be included in the future. Details here